Article Date: 9/1/2008

CLINICAL TRIAL UPDATE

CLINICAL TRIAL UPDATE

DRY AMD
Study: Measuring Reading Rehabilitation Outcomes
Sponsor: Dept. of Veterans Affairs
Status: Enrolling patients
Purpose: To measure the effectiveness of a newly designed oculomotor training program for patients with AMD
Design: Educational, Counseling, Training, Nonrandomized, Double-blind, Active-control, Crossover Assignment, Efficacy Study
Number of Patients: 90
Inclusion Criteria: Established preferred retinal locus; VA of ≤20/70 and ≥20/400 (in the better eye)
Exclusion Criteria: Major ophthalmologic and neurologic disease; CNV ("wet" AMD); moderate to severe media opacities; and cognitive impairment
Information: (312) 996-1466

Study: Effects of Sun Filters on Age-Related Macular Degeneration in People With Lens Implants
Sponsor: National Institute of Child Health and Human Development (NICHD)
Status: Currently enrolling
Purpose: To test a new method for preventing worsening of AMD and for developing imaging methods to follow the very earliest microscopic changes in the disease
Design: Natural History, Longitudinal, Defined Population, Prospective Study
Number of Patients: 40
Inclusion Criteria: Patients will be local area residents who average greater than or equal to 2 hours outdoors daily, who are willing to follow the protocol of wearing bicolor sunglasses whenever outdoors in daylight, to keep a log book of use, and to return periodically to NICHD for non-invasive imaging studies
Exclusion Criteria: Wet AMD; prior eye disorders; diabetes or current chemotherapy
Information: (800) 411-1222

Study: Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-Related Macular Degeneration
Sponsor: The New York Eye and Ear Infirmary
Status: Currently enrolling
Purpose: To investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone, which had been proven as a safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet AMD
Design: Treatment, Randomized, Double-blind (Subject, Outcomes Assessor), Placebo-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Dry AMD in 1 or both eyes; age ≥50; either gender
Exclusion Criteria: Known sensitivity to mannitol or copaxone; skin disease or active infection of skin; active fever or active treatment for infection; history of other uncontrolled systemic active disease; premenopausal females not using reliable birth control; sensitivity to fluorescein or iodine
Information: ktai@nyee.edu

Study: Safety Study in Retinal Transplantation for Dry Age-Related Macular Degeneration
Sponsor: Ocular Transplantation; National Neurovision Research Institute
Status: Currently enrolling
Purpose: To show that retinal transplantation can help to prevent blindness and restore eyesight in patients with dry AMD
Design: Treatment, Nonrandomized, Open-label, Active-control, Factorial Assignment, Safety/Efficacy Study
Number of Patients: 10
Inclusion Criteria: The subject must have decreased central VA of 20/200 or worse in 1 eye by ETDRS vision testing for a duration of at least 1 year in the operated eye and have the diagnosis of AMD; vision in the nonoperated eye must be better than the operated eye. Vision in the operated eye cannot be better than 20/200; subject is older than 55 years of age; patient has undergone microperimetry and Goldmann visual field testing
Exclusion Criteria: Patient having central visual acuity of >20/200 in 1 eye by ETDRS or vision worse than 20/200 in 1 eye by ETDRS for a duration of less than 1 year; patient under 55 years of age; patient having medical problems that are contraindicatory for short-term anesthesia; features of any condition other than AMD in the study eye (such as pathologic myopia or presumed ocular histoplasmosis) associated with CNV; any significant ocular disease (other than CNV) that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome; inability to obtain photographs to document CNV, including difficulty with venous access; history of CNV in the study eye; participating in another ophthalmic clinical trial or use of any other investigational new drugs within 12 weeks before the start of study treatment; prior photodynamic therapy or Macugen therapy for CNV; patient who has a history of uveitis, Coat's disease, diabetic retinopathy, glaucoma, or a cataract that prevents visualization of the posterior pole
Information: nradtke@prodigy.net

Study: Safety and Tolerability of ACU-02 in Healthy Volunteers for Potential Therapy for Dry Age-related Macular Degeneration
Sponsor: Acucela, Inc.
Status: Enrolling subjects
Purpose: To provide an initial evaluation of the safety and tolerability of single-dose oral administration of ACU-02 in healthy volunteers in dose-escalating cohorts
Design: Phase I, Randomized, Double-masked, Placebo-controlled, Dose-escalating Safety Study
Number of Patients: Up to 30
Inclusion Criteria: Age >55 and <80 years; healthy as determined by medical history and physical examination
Information: www.acucela.com

WET AMD
Study: Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD
Sponsor: OSI/Pfizer
Status: Enrolling patients
Purpose: To explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment
Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single-group Assignment
Number of Patients: 1000
Inclusion Criteria: Patients must have 1, but not more than 3, prior treatments for neovascular AMD
Information: (866) 622-8436

Study: Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to AMD
Sponsor: Vitreous Retina Macula Consultants of New York; Genentech
Status: Enrolling patients
Purpose: To determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed CNV
Design: Treatment, Nonrandomized, Open-label, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 15
Inclusion Criteria: BCVA letter score in the study eye between 73 and 24 (approximately 20/40 to 20/320) using an ETDRS chart; CNV lesion of any type in the study eye; evidence that CNV extends under the geometric center of the foveal avascular zone; area of the CNV must occupy at least 50% of the total lesion; lesion must be ≤4000 μm in greatest linear dimension (GLD)
Exclusion Criteria: History of prior PDT, external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye; atrophy under the center of the fovea; angioid streaks, presumed ocular histoplasmosis syndrome, myopia (>6 D), or CNV secondary to causes other than AMD; receiving or require chronic concomitant therapy with systemic (>5 mg) or ocular corticosteroids
Contact: (212) 452-6902

Study: Study to Determine Safety/Efficacy of Lucentis for Treatment of Retinal Angiomatous Proliferation Secondary to AMD
Sponsor: The National Retina Institute/Genentech
Status: Enrolling patients
Purpose: To determine the safety and efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to AMD
Number of Patients: 20
Inclusion Criteria: Age >50 years; definite characteristic signs of AMD, including drusen; presence of retinal angiomatous proliferation as determined by clinical signs (intraretinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on FA, hot spot on static ICG, visible RAP lesion on high speed ICG)
Exclusion Criteria: Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye; treatment with verteporfin in the nonstudy eye less than 7 days preceding day 0; previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.); previous subfoveal focal laser photocoagulation involving the foveal center in the study eye; laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0; history of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye; previous participation in any studies of investigational drugs within 1 month preceding day 0 (excluding vitamins and minerals)
Contact: (301) 986-8747

Study: LUV: Lucentis Utilizing Visudyne Combination Therapy in the Treatment of Age-Related Macular Degeneration
Sponsor: Novartis/Greater Houston Retinal Research
Status: Currently enrolling
Purpose: To determine whether the combination of ranibizumab and PDT is an effective and safe treatment for AMD
Design: Treatment, Randomized, Open-label, Dose-comparison, Parallel Assignment, Efficacy Study
Number of Patients: 30
Inclusion Criteria: Age >55 years; subfoveal neovascular membrane confirmed by FA and/or ICG; VA not better than 20/32 and not worse than 20/320 by ETDRS refraction
Exclusion Criteria: Previous vitrectomy; intracapsular cataract extraction; previous treatment with ranibizumab, bevacizumab, triamcinolone, or PDT; history of retinal detachment; significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12-month study; prior enrollment in any study for AMD
Information: http://www.houstonretina.com/

Study: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization
Sponsor: Novartis
Status: Currently enrolling
Purpose: To evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with CNV secondary to AMD
Design: Treatment, Randomized, Double-blind, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 318
Inclusion Criteria: Subjects of either gender age 50 years or older; subfoveal CNV due to AMD
Exclusion Criteria: Choroidal neovascularization due to causes other than AMD; prior treatment for neovascular AMD in the study eye
Information: Brandi Teske, bteske@westcoastretina.com

Study: A Phase I Trial of a Single Intravitreal Injection of REDD14NP to Patients With CNV Secondary to Wet AMD
Sponsor: Quark Biotech, Inc.
Status: Enrolling patients
Purpose: To determine the safety and pharmacokinetics of REDD14NP when administered as a single intravitreal injection
Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single-group Assignment, Safety Study
Number of Patients: 42
Inclusion Criteria: Documented CNV secondary to AMD; clear ocular media and adequate pupil dilation; IOP ≤25 mm Hg; retinal thickness >250 μm by OCT; BCVA not better than 20/200
Exclusion Criteria: Women of childbearing potential; CNV due to causes other than AMD; underlying disease or other disease of the eye; therapy for AMD in either eye in last 30 days; steroid therapy for AMD in last 6 months; history of intraocular surgery other than cataract surgery or of retinal detachment in the study eye
Information: (212) 452-6902

Study: Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced-Fluence PDT in Patients With Wet AMD
Sponsor: Barnes Retina Institute
Status: Enrolling patients
Purpose: To determine the benefits, if any, of combination therapy with Lucentis plus reduced-fluence PDT with Visudyne
Design: Treatment, Randomized, Open-label, Active-control, Single-group Assignment, Safety/Efficacy Study
Inclusion Criteria: Treatment-naïve patients with active, subfoveal, exudative AMD; VA of 20/40 to 20/320 in the study eye; subfoveal CNV must be at least 50% of the total lesion size; total area of lesion components other than CNV must be less than 50% of the total lesion size; lesion must be <5400 μm in greatest linear dimension; lesion size <10 disc areas
Exclusion Criteria: Previous treatment for CNV with anti-VEGF agents, intraocular steroids, and/or PDT with Visudyne; geographic atrophy or fibrosis in the study eye; intraocular surgery within 6 weeks of enrollment; subretinal hemorrhage >50% of the total lesion; OP greater than 30 mm Hg on 2 pressure-lowering medications; severe disciform scarring; advanced glaucoma; allergies to porfins or a known hypersensitivity to any component of Visudyne; porphyria, pregnancy, or lactation
Information: bristudies@barnesretinainstitute.com

Study: ASaP: Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration
Sponsor: Potentia Pharmaceuticals, Inc.
Status: Currently enrolling
Purpose: To provide initial safety and tolerability information for a larger phase 2 study of intravitreal POT-4 and for phase 1 studies of POT-4 slow-release formulations for treatment of patients with AMD.
Design: Prospective, Uncontrolled, Nonrandomized, Single-masked, Single-dose Escalation Study
Number of Patients: 18
Inclusion Criteria: Age ≥50 years; in the study eye, diagnosis of exudative AMD defined by the presence of drusen larger than 63 μm and presence of a choroidal neovascular lesion, either predominantly or minimally classic or occult with no classic in nature, determined by the Digital Angiography Reading Center (DARC) with the CNV defined by its FA features; lesion must contain some visible active CNV, but the active CNV need not be under the fovea itself; visual acuity of 20/100 or worse in the study eye as measured on an ETDRS chart
Exclusion Criteria: Choroidal neovascularization in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (eg, as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy. Participants who have any additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant DME, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy; decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; cataract surgery within 3 months of enrollment; presence of hemorrhage greater than 50% of the CNV lesion; history of treatment for CNV in the study eye, peribulbar corticosteroid injection within 6 months prior to the start of the trial, or oral steroid use at any time during the 30 days prior to randomization; intraocular surgery (including lens replacement surgery) within 6 weeks prior to randomization; medical problems that make consistent follow-up over the treatment period unlikely (eg, stroke, severe MI, endstage malignancy), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections; history of coronary artery disease or cerebral vascular disease; hypersensitivity to fluorescein
Information: federico@potentiapharma.com

Study: A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD
Sponsor: Oregon Health and Science University
Status: Currently enrolling
Purpose: To understand whether genes or certain factors in the environment determine how eyes will respond to Lucentis (ranibizumab) treatment
Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single-group Assignment, Efficacy Study
Number of Patients: 300
Inclusion Criteria: Age >50 years; study eye must never have received treatment for neovascular AMD; VA in treatment eye must be between 20/30 and 20/320 (ETDRS)
Exclusion Criteria: Choroidal neovascularization not from AMD; concomitant non-AMD related maculopathy in study eye; active treatment for neovascular AMD in fellow eye; acuity loss or central field loss from non-AMD cause; pigment epithelial detachment without evidence of CNV; individuals in whom Lucentis is contraindicated; pregnancy (positive pregnancy test) or lactation; premenopausal women not using adequate contraception
Information: (503) 494-3616

Study: CABERNET: Study of Strontium90 Beta Radiation With Lucentis to Treat AMD
Sponsor: Neo Vista
Status: Enrolling patients
Purpose: To evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal CNV associated with wet AMD
Design: Treatment, Randomized, Open-label, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 450
Inclusion Criteria: Must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of <12 total disc areas (21.24 mm2), and a GLD ≥5.4 mm; must be age 50 or older
Exclusion Criteria: Prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic antiangiogenic or intravitreal antiangiogenic agents in study eye; previous radiation therapy to the eye, head, or neck; diagnosis of diabetes
Information: (510) 933-7650, info@neovistainc.com

Study: COBALT: Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD
Sponsor: Opko Health, Inc.
Status: Currently enrolling
Purpose: To compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pretreatment with 3 injections of Lucentis compared to Lucentis given every 4 weeks to people with wet AMD. Patients will be assigned at random to receive 1 of 3 treatments options for 104 weeks
Design: Treatment, Randomized, Double-blind, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 330
Inclusion Criteria: Age ≥50 years old; predominantly classic, minimally classic or occult with no classic lesions secondary to AMD; ETDRS BCVA of 69 to 24 letters (20/40 to 20/320 Snellen equivalent)
Exclusion Criteria: Any intraocular surgery of the study eye within 12 weeks of screening; previous posterior vitrectomy of the study eye; advanced glaucoma or IOP >22 mm Hg in the study eye despite treatment
Information: clinicaltrials@opko.com

Study: Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-Related Macular Degeneration
Sponsor: University of California, Davis/Genentech
Status: Currently enrolling
Purpose: To determine whether treating wet macular degeneration with a combination of Lucentis and proton beam irradiation is safe
Design: Natural History, Longitudinal, Defined Population, Prospective Study
Inclusion Criteria: Age >50 years; women must be postmenopausal without a period for at least 1 year; Hgb A1C <6; VA 20/60 to 20/400; lesion size <12 disc area; submacular hemorrhage less than 75% of total lesion; submacular fibrosis less than 25% of total lesion
Exclusion Criteria: PDT within 3 months; anti-VEGF therapy within 6 weeks; intravitreal or sub-Tenon's Kenalog within 6 months; intraocular surgery within 3 months or expected in the next 6 months; other concurrent retinopathy or optic neuropathy
Information: (916) 734-6303

Study: Double-Masked Study of Efficacy and Safety of IVT VEGF Trap-Eye in Subjects With Wet AMD (VIEW 1)
Sponsor: Regeneron/Bayer
Status: Currently enrolling
Purpose: To study the efficacy and safety of VEGF-Trap-Eye in patients with neovascular AMD
Design: Treatment, Randomized, Double-blind, Active-control, Parallel Assignment
Number of Patients: 1200
Inclusion Criteria: Men and women ≥50 years of age; active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye; ETDRS BCVA of 20/40 to 20/320 (letter score of 73 to 25) in the study eye
Exclusion Criteria: Any prior treatment with anti-VEGF agents; total lesion size >12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye; subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded 270° by visible CNV); scar or fibrosis, making up >50% of total lesion in the study eye; scar, fibrosis, or atrophy involving the center of the fovea
Information: vegf.trap@regeneron.com

Study: A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD
Sponsor: Jerini Ophthalmic
Status: Currently enrolling
Purpose: To determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin 5 1-antagonist is absorbed, broken down, and eliminated from the body when it is given as a single dosage strength by injection into the eye
Design: Treatment, Open-label, Uncontrolled, Single Group Assignment, Safety Study
Number of Patients: 36
Inclusion Criteria: Best-corrected visual acuity in the study eye between 20/40 and 20/320, and better or equal to 20/40 in the fellow eye using an ETDRS chart; subfoveal CNV due to AMD; total area of the lesion (including blood, neovascularization and scar/atrophy) must be ≥12 DA, of which at least 50% must be active CNV; for patients with occult or nonclassic CNV; there must be the presence of subretinal hemorrhage (but still comprising no more than 50% of the lesion) and/or documented evidence of 3 or more lines of vision loss (ETDRS or equivalent) during the previous 12 weeks; clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening; intraocular pressure of 21 mm Hg or less; retinal thickness ≥250 μm by OCT.
Exclusion Criteria: Any prior PDT in the study eye; previous therapeutic radiation to the eye; any retinovascular disease or retinal degeneration other than AMD; serous pigment epithelial detachment without the presence of neovascularization; presence of pigment epithelial tears or rips; previous posterior vitrectomy or retinal surgery; any periocular infection in the past 4 weeks
Information: (919) 226-1440 ×325

Study: Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST)
Sponsor: Retina Vitreous Associates, P.C.; Genentech
Status: Currently enrolling
Purpose: To test the safety, tolerability and effectiveness of a higher dose (1.0 mg) of ranibizumab versus the standard dose (0.5 mg), in adults with age-related macular degeneration who have never been treated with ranibizumab.
Design: Treatment, Randomized, Open-label, Parallel Assignment
Number of Patients: 30
Inclusion Criteria: Treatment-naïve macular degeneration patients with CNV; >50 years old; visual acuity 20/40 to 20/320
Exclusion Criteria: Pregnancy or previous history of thromboembolic event including myocardial infarction or stroke
Information: cawh@aol.com

Study: Sensitivity of the Home Macular Perimeter (HMP)
Sponsor: Notal Vision Ltd
Status: Currently enrolling
Purpose: To estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD
Design: Cohort, Prospective
Number of Patients: 20
Inclusion Criteria: Subjects with AMD related lesions: New onset (up to 60 days) nontreated CNV; age >50 years; VA with habitual correction >20/200 in study eye; familiar with computer usage
Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in the study eye; presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP, or FA; any non-macular-related ocular surgery performed within 3 months prior to study entry in the targeted eye; inability to tolerate intravenous FA; participation in another study with the exclusion of AREDS study
Information: osnat@notalvision.com

Study: A Study to Evaluate the Pharmacodynamics, Safety, and Pharmacokinetics of Pazopanib Drops in Adult Subjects With Neovascular AMD
Sponsor: GlaxoSmithKline
Status: Currently enrolling
Purpose: To evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients
Design: Treatment, Randomized, Double-blind, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
Number of Patients: 60
Inclusion Criteria: Age-related macular degeneration patients diagnosed with subfoveal CNV in the study eye, with all of the following characteristics required: central subfield thickness >300 μm on investigator-determined OCT (inclusive of subretinal fluid); active subfoveal leakage as determined by investigator-determined FA; minimally classic or occult with no classic CNV lesion; lesion size no greater than 12 disc areas; CNV <50% of lesion area; <50% of lesion area with blood; >25% of lesion area with fibrosis; best-corrected ETDRS VA in the study eye between 80 to 24 letters inclusive (approximately 20/25 and 20/320 or 4/5 to 4/63) at screening
Exclusion Criteria: Additional eye disease in the study eye that could compromise BCVA (ie, glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, or retinitis pigmentosa); CNV in the study eye due to other causes unrelated to AMD; presence of retinal angiomatous proliferation (RAP) in the study eye, as determined by the investigator (confirmation by indocyanine green angiography is not required); geographic atrophy involving the center of the fovea in the study eye; anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation of the fundus for photographs, FA and OCT; vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD; more than 1 prior photodynamic therapy (PDT) treatment in the study eye
Information: (877) 379-3718

Study: Phase 1, Safety, Tolerability, and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration
Sponsor: Ophthotech Corp.
Status: Currently enrolling
Purpose: To evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to AMD
Design: Treatment, Open-label, Single-group Assignment, Safety/Efficacy Study
Number of Patients: 18
Inclusion Criteria: Subfoveal CNV due to AMD
Exclusion Criteria: Diabetic retinopathy; history or evidence of severe cardiac disease; history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation; clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function; stroke (within 12 months of trial entry); any major surgical procedure within 1 month of trial entry. Previous therapeutic radiation in the region of the study eye; any treatment with an investigational agent in the past 60 days for any condition
Information: denise.teuber@ophthotech.com

Study: CATT: Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule
Design: Treatment, Randomized, Double-blind (Caregiver, Investigator, Outcomes Assessor), Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 1200
Inclusion Criteria: Active, subfoveal choroidal neovascularization (CNV); subretinal hemorrhage and fibrosis <50% of total lesion area; VA 20/25 to 20/320; age ≥50 yrs; at least 1 druse (>63 μm) in either eye or late AMD in fellow eye
Exclusion Criteria: Previous treatment for CNV in study eye; other progressive retinal disease likely to compromise VA; contraindications to injections with Lucentis or Avastin
Information: dan.martin@emory.edu

Study: Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
Sponsor: CoMentis
Status: Currently enrolling
Purpose: To study the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab
Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 60
Inclusion Criteria: > 55 years of age; clinical diagnosis of neovascular AMD
Exclusion Criteria: Confounding ocular condition
Information: jmonk@comentis.com

Study: Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To examine whether the antiinflammatory medicines infliximab, sirolimus or daclizumab, when given with a patient's current therapies, will prevent the growth of new blood vessels in the eye in patients with AMD
Design: Treatment, Randomized, Open-label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Age ≥55 years; in the study eye, diagnosis of AMD defined by the presence of drusen larger than 63 μm; any antiangiogenic therapy in the study eye within 7 days of beginning immunosuppressive therapy; in the study eye, the participant's study eye vision is between 20/20 and 20/400; in the study eye, the presence of CNV under the fovea determined by NEI Investigators; VA of 20/400 or better as measured on an ETDRS chart
Exclusion Criteria: Choroidal neovascularization, in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; presence of geographic atrophy under the fovea in the study eye; evidence of retinal angiomatous proliferation as suspected by the presence of intraretinal hemorrhage, intraretinal leakage, adjoining serous PED or the presence of a connecting retinal vessel; presence of a chorioretinal anastomosis; decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane; decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; a tear (rip) of the RPE; a vitelliform-like lesion of the outer retina (eg, as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy; presence of fibrosis, hemorrhage, pigment epithelial detachments and other hypofluorescent lesions obscuring greater than 50% of the CNV lesion; history of other systemic antiangiogenic treatment or treatment for CNV (not including photodynamic therapy and pegaptanib sodium injections) in the study eye with transpupillary thermotherapy or other local treatment (such as submacular surgery); participant with a known underlying systemic disease with evidence of serious or potentially lethal uncontrolled active disease in 1 or more extraocular organ systems for which a defined effective medical regimen is indicated; participant with a corneal melting, necrotizing keratitis, or impending vision loss
Information: (800) 411-1222

Study: Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-VEGF Treatment in Patients With Age-Related Macular Degeneration
Sponsor: Allergan
Status: Currently enrolling
Purpose: To evaluate the safety and efficacy of the intravitreal implant of dexamethasone with anti-VEGF treatment vs anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to AMD
Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Outcomes Assessor), Active-control, Single-group Assignment, Safety/Efficacy Study
Number of Patients: 200
Inclusion Criteria: >50 years old with subfoveal CNV secondary to AMD; VA between 20/40 and 20/400 in the study eye
Exclusion Criteria: Any intraocular surgery within 3 months; glaucoma or cataract; high IOP; uncontrolled systemic disease
Information: clinicaltrials@allergan.com

Study: The MAP Study: FA/Medidur for AMD Pilot
Sponsor: Johns Hopkins University/Alimera Sciences
Status: Currently enrolling
Purpose: To compare the safety of 2 doses of FA/Medidur in conjunction with Lucentis (as needed) in patients with neovascular AMD who have have been treated with Lucentis for at least 6 months and have reached a plateau
Design: Treatment, Randomized, Single-blind (Subject), Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Patients ≥50 years old; treated with intraocular injections of Lucentis for at least 6 months and have reached a plateau, defined as 2 consecutive visits (4 to 6 weeks apart) with no improvement in VA (worse or within 1 line better) or center subfield thickening (worse or within 30 μm better); BCVA 20/320 or better in the study eye
Exclusion Criteria: Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, ie, double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD); glaucoma or ocular hypertension (defined as IOP >21 mm Hg or concurrent therapy at screening with IOP-lowering agents) in the study eye; laser or photodynamic therapy within 12 weeks of screening; any ocular surgery in the study eye within 12 weeks of screening; YAG capsulotomy in the study eye within 15 days of screening; treatment with intravitreal, sub Tenon's, or periocular steroid or anti-VEGF therapy other than Lucentis within 6 months prior to enrollment (eg, triamcinolone injection, Avastin, Macugen). Systemic treatment with Avastin is also not allowed within 6 months prior to screening or at any time during the study
Information: ghafiz1@jhmi.edu

Study: Antioxidant Systems and Age-Related Macular Degeneration
Sponsor: Vanderbilt University/National Institutes of Health
Status: Currently enrolling
Purpose: To determine whether the antioxidant supplements used in AREDS shifted the plasma pool of the AREDS subjects to a more reduced state
Design: Case-only, Prospective
Number of Patients: 140
Inclusion Criteria: Age 55-80; intermediate or advanced AMD; willing to give written informed consent, make the required study visits, and follow instructions; any race and either sex
Exclusion Criteria: Current history of a medical condition that would preclude scheduled study visits or completion of the study (eg, unstable cardiovascular disease, unstable pulmonary disease, chronic hepatitis, or AIDS); current or history of an ophthalmic disease in the study eye (other than AMD) that would likely compromise or during follow-up could likely compromise the visual acuity of the study eye (eg, amblyopia, uncontrolled glaucoma with an IOP >30 mm Hg, ischemic optic neuropathy, proliferative diabetic retinopathy, clinically relevant nonproliferative diabetic retinopathy, clinically relevant diabetic macular edema, significant active uveitis); clinical signs of myopic retinopathy, or a refraction of >8 D power in current prescription; aphakic or pseudophakic patients may be enrolled if there is no funduscopic evidence of degenerative myopia present and if there is no medical history prior to the patient's cataract surgery of either myopic retinopathy or a refraction of >8 D; intraocular surgery in study eye (eye to be treated) within 60 days prior to enrollment; presence of a scleral buckle in the study eye
Information: paul.sternberg@vanderbilt.edu

Study: High Speed Indocyanine Green Angiography Findings in Ranibizumab Treatment for Wet Age-Related Macular Degeneration
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To use an eye imaging test called high speed indocyanine green angiography (HS-ICG), which examines leaky vessels in the eye, to try to find out why individuals respond differently to ranibizumab (Lucentis) treatment for wet age-related macular degeneration (AMD)
Design: Prospective
Number of Patients: 50
Inclusion Criteria: Must be ≥50 years old; must be diagnosed with AMD in at least one eye defined by the presence of drusen at least 63 μm in size; must have CNV secondary to AMD as determined by the investigator; must have VA of better than 20/400 in the affected eye as measured on an ETDRS chart
Exclusion Criteria: CNV, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; geographic atrophy or fibrosis under the fovea; decreased vision due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis, or epiretinal membrane; additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant DME, severe nonproliferative diabetic retinopathy, or proliferative diabetic retinopathy; decreased vision due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; a tear of the RPE; a vitelliform-like lesion of the outer retina (eg, as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy; history of treatment for CNV in the study eye with verteporfin/photodynamic therapy, transpupillary thermotherapy, external beam radiation therapy, or other local treatment (such as submacular surgery); previous subfoveal focal laser photocoagulation (juxtafoveal or extrafoveal) in the study eye; previous ranibizumab, bevacizumab or pegaptanib sodium treatments in the study or fellow eye less than 4 weeks prior to enrollment; prior verteporfin/photodynamic therapy in the fellow eye less than 1 week prior to enrollment; prior intravitreal or peribulbar corticosteroids in the study or fellow eye less than 12 weeks prior to enrollment; evidence of ocular toxoplasmosis; external ocular infection, including conjunctivitis; chalazion; significant blepharitis; or aphakia in the study eye; history of systemic anti-VEGF therapy less than 4 weeks prior to enrollment or will be starting systemic anti-VEGF therapy while on the protocol; intraocular surgery (including lens replacement surgery) within 6 weeks prior to enrollment; history of (within the last 6 months), or current ocular or periocular infection (including any history of ocular herpes zoster or simplex); prior vitrectomy; history of systemic or topical steroid use at any time during the 30 days prior to enrollment; has participated in any other clinical study or is receiving, or has received any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment; has had insertion of a scleral buckle in the study eye; clinical evidence of scleral thinning (defined as an area of blue/grey discoloration of the sclera representing visualization of underlying choroidal tissue through a thinned area of sclera) seen at the time of external eye examination; exhibits clinical signs of myopic retinopathy, or has a refraction of greater than spherical equivalent -8.00 D in their current prescription. Pseudophakic participants may be enrolled in this study if there is no funduscopic evidence of degenerative myopia present and if there is no medical history prior to the participant's cataract surgery of either myopic retinopathy or a refraction of greater than spherical equivalent -8.00 D
Information: prpl@mail.cc.nih.gov

Study: Study of Efalizumab Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration (SEIRA)
Sponsor: Vitreous-Retina Macula Consultants of New York/Genentech
Status: Enrolling patients
Purpose: To study a combination therapy using efalizumab and ranibizumab that could target the adhesion factors that precede angiogenesis and improve the outcome for AMD patients in combination with the anti-VEGF agent, ranibizumab
Design: Treatment, Non-Randomized, Open-label, Uncontrolled, Single-group Assignment
Number of Patients: 10
Inclusion Criteria: Demonstrate understanding of and ability to perform weekly self subcutaneous injections; subjects of either gender, age >50 years; best corrected visual acuity in the study eye between 20/40 and 20/320; subfoveal choroidal neovascularization, secondary to age related macular degeneration. 6-10 anti-VEGF treatments allowed prior to enrollment; presence of subretinal fluid and/or cystoid retinal edema on OCT; presence of fibrosis, hemorrhage, serous pigment epithelial detachments, tear (rip) of the retinal pigment epithelium or other hypofluorescent lesions should not obscure greater than 50% of the CNV lesion; annual immunization completed at least 4-6 weeks prior to BSL; clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography
Exclusion Criteria: Pregnancy (positive pregnancy test) or lactation; premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch; had prior treatment with Photodynamic Therapy (PDT); had treatment with anti-VEGF agents within 30 days prior to BSL; had treatment with Kenalog within 6 months prior to BSL; had treatment with Dexamethaosne within 30 days prior to BSL; had ocular surgery within the past 60 days in the study eye; concurrent use of more than two therapies for glaucoma; uncontrolled glaucoma in the study eye (defined as intraocular pressure >30 mm Hg despite treatment with anti-glaucoma medication); concurrent use of systemic anti-VEGF agents; has active infection in the study eye; inability to obtain photographs to document CNV; has received investigational therapy within 60 days prior to study entry; patients with significantly compromised visual acuity in the study eye due to concomitant ocular conditions
Information: (212) 452-6965

Study: RC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Lucentis 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration
Sponsor: Ophthotech Corporation
Status: Currently enrolling
Purpose: To evaluate the safety, tolerability, and pharmacokinetic profile of multiple doses of ARC1905 intravitreous injection when administered in combination with multiple doses of Lucentis 0.5 mg/eye, or with 1 induction dose of Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD)
Design: Treatment, Non-Randomized, Open-label, Uncontrolled, Single Group Assignment, Safety Study
Number of Patients: 70
Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD (i.e., predominately classic, minimally classic or occult no classic) as documented by fluorescein angiogram
Exclusion Criteria: Previous or concomitant therapy with intravitreous corticosteroids; any of the following underlying diseases including: diabetic retinopathy; history or evidence of severe cardiac disease (eg, NYHA Functional Class III or IV), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment; history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation; clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function. Patients with results outside these ranges may be enrolled in consultation with Ophthotech
Information: dbeutelspacher@ophthotech.com

Study: Subretinal Lucentis for Hemorrhagic AMD
Sponsor: William Beaumont Hospitals
Status: Currently enrolling
Purpose: To determine if subretinal Lucentis alone is beneficial: 5 of the 10 patients enrolled will get a gas bubble and the other 5 will not
Design: Treatment, Randomized, Open-label, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 10
Inclusion Criteria: Age over 50 years; vision 20/200 or worse; AMD with submacular hemorrhage; hemorrhage more than 25% of the lesion; fibrosis or scar not more than 25% of the entire lesion; hemorrhage less than 3 months old; vision loss occuring within 3 months
Exclusion Criteria: Intraocular eye surgery within the previous 12 months; inability to obtain necessary eye photographs; systemic use of anti-VEGF agents; allergy to fluorescein dye; glaucoma filtering surgery; use of 2 or more treatments for glaucoma; lack of lens in the eye or absence of a posterior capsule
Information: tosetoski@beaumont.edu

Study: Reduced Fluence PDT With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
Sponsor: Oklahoma State University Center for Health Sciences/Novartis
Status: Currently enrolling
Purpose: To compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative AMD
Design: Treatment, Randomized, Open-label, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Male or Female Patients >50 years of age; patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT; BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. See definition of ETDRS charts; if both eyes are eligible, only one eye will be evaluated in the study. The eye with lesser visual acuity will be selected as the study eye
Exclusion Criteria: Patients receiving prior treatment in the study eye with verteporfin, any focal laser photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab; neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease; choroidal neovascular membrane greater than 9 disc diameters in size; previous posterior vitrectomy in the study eye; concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period
Information: (918) 747-7799

Study: Pilot Study Reduced Fluence PDT/Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-Related Macular Degeneration (AMD)
Sponsor: Lahey Clinic
Status: Currently enrolling
Purpose: To determine if combination reduced fluence photodynamic therapy and Ranibizumab has similar efficacy to Ranibizumab (Lucentis) alone
Design: Treatment, Randomized, Single-blind (Caregiver), Active-control, Parallel Assignment
Number of Patients: 20
Inclusion Criteria: Male/Female >50 years of age; FA diagnosis of CNV lesions as described above; best corrected visual acuity letter score in the study eye between 72-24 letters (approximately 20/40 to 20/320) using ETDRS chart measured at 4 meters; central retinal (including lesion) thickness greater than or equal to 250 μm as measured by OCT; subretinal hemorrhage making up less than 50% of total lesion size and sparing the fovea; sufficiently clear ocular media including the lens to allow photography of the retina
Exclusion Criteria: Dense subfoveal hemorrhage (>50% of the lesion); tear or rip of the retina pigment epithelium, idiopathic parafoveal telangiectasis or serous pigment epithelial detachment without CNV; geographic atrophy involving the foveal center; subretinal fibrotic scar in the study eye greater than 25% of the lesion; presence of any condition in study eye other than AMD known to be associated with CNV; history diabetic retinopathy or diabetic macular edema
Information: Avon.P.Stewart@Lahey.org

Study: SEAGUL: Study Evaluating Genotypes Using Lucentis
Sponsor: University of Utah/Genentech
Status: Currently enrolling Purpose To investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms
Design: Treatment, Open-label, Uncontrolled, Single-group Assignment, Efficacy Study
Inclusion Criteria: Treatment naive AMD patients; at least 50 years of age; visual acuity between 20/40 and 20/320
Exclusion Criteria: Pregnancy; prior enrollment in a ranibizumab clinical trial; previous therapy in either eye for AMD; concurrent eye disease that could compromise visual acuity
Information: jeanette.buehler@hsc.utah.edu

DIABETIC MACULAR EDEMA
Study: Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Sponsor: Allergan
Status: Enrolling patients
Purpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of DME
Design: Treatment, Randomized, Double-blind, Dose-comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 860
Inclusion Criteria: Diagnosis of DME; decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse), other eye no worse than 20/200
Exclusion Criteria: Known anticipated need for ocular surgery within next 12 months; history of glaucoma or current high eye pressure requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids or warfarin/heparin
Information: clinicaltrials@allergan.com

Study: Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema (LRT for DME)
Sponsor: NEI/Genentech/Allergan
Status: Currently enrolling
Purpose: To find out which is a better treatment for DME: laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone
Design: Treatment, Randomized, Single-blind, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 701
Inclusion Criteria: Age ≥18 years; diagnosis of diabetes mellitus (type 1 or type 2)
Exclusion Criteria: Significant renal disease; participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry; known allergy to any component of the study drug; blood pressure >180/110 (systolic above 180 OR diastolic above 110); myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization; systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization; pregnancy
Information: (866) 372-7601 ×218

Study: Effect of Ruboxistaurin on Clinically Significant Macular Edema
Sponsor: Eli Lilly and Company
Status: Currently enrolling
Purpose: To test the hypothesis that oral administration of ruboxistaurin for approximately 18 months will reduce the baseline to endpoint changes in macular thickness, as measured by OCT, in patients with clinically significant macular edema
Design: Treatment, Randomized, Double-blind, Placebo-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 220
Inclusion Criteria: Type 1 or 2 diabetes; ≥18 years old; HbA1c less than or equal to 11%; mild to very severe nonproliferative diabetic retinopathy in the study eye; clinically significant macular edema in the study eye
Exclusion Criteria: Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye; glaucoma in the study eye; unstable cardiovascular disease; major surgery within past 3 months; significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy
Information: (877) 285-4559

Study: Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy
Sponsor: NEI/Genentech/Allergan
Status: Currently enrolling
Purpose: To find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment
Design: Treatment, Randomized, Single-blind, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 380
Inclusion Criteria: Type 1 or 2 diabetics age ≥18 years
Exclusion Criteria: Prior panretinal photocoagulation that was sufficiently extensive that the investigator does not believe that at least 1200 additional burns are needed or possible within 49 days after randomization; macular edema is considered to be due to a cause other than DME; ocular condition is present such that, in the opinion of the investigator, preventing VA loss would not improve from resolution of macular edema; substantial cataract that, in the opinion of the investigator, is likely to be decreasing VA by 3 lines or more (ie, cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal); history of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment)
Information: (866) 372-7601

Study: RISE: A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus
Sponsor: Genentech
Status: Currently enrolling
Purpose: To study the efficacy and safety of ranibizumab injection in patients with CSME-CI secondary to diabetes mellitus (Type 1 or 2)
Design: Treatment
Number of Patients: 366
Inclusion Criteria: Retinal thickening secondary to diabetes mellitus involving the center of the fovea with central macular thickness >275 μm in the center subfield, as assessed on OCT and confirmed by the central reading center at screening and by the evaluating physician on day 0; known duration of DME of ≥2 years; BCVA score in the study eye of 20/40 to 20/320 approximate Snellen equivalent using the ETDRS protocol at an initial testing distance of 4 meters, confirmed by the investigator; decrease in vision determined to be the result of DME and not due to other causes
Exclusion Criteria: History of vitreoretinal surgery in the study eye; panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of study entry; previous use of intraocular corticosteroids in the study eye (eg, TA) within 3 months of study entry; previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within 3 months of study entry; PDR in the study eye, with the exception of inactive, fibrotic PDR that has regressed following panretinal laser photocoagulation; iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in the study eye
Information: lane.hayley@gene.com

Study: A Study of the Safety and Efficacy of a New Treatment in Combination With Laser for Macular Edema Resulting From Diabetic Macular Edema
Sponsor: Allergan
Status: Enrolling patients
Purpose: To evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs laser treatment alone in patients with DME
Design: Treatment, Randomized, Single-blind, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 250
Inclusion Criteria: Decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse) and VA in other eye no worse than 20/200
Exclusion Criteria: History of glaucoma or current high IOP requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids; use of warfarin/heparin
Information: clinicaltrials@allergan.com

Study: A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin for Treatment of Patients With DME
Sponsor: ThromboGenics
Status: Currently enrolling
Purpose: To compare multiple doses of intravitreal microplasmin for nonsurgical PVD induction for treatment of patients with DME
Design: Treatment, Randomized, Double-blind, Dose-comparison, Single-group Assignment, Safety/Efficacy Study
Number of Patients: 60
Inclusion Criteria: >18 years old with DME
Exclusion Criteria: PVD present at baseline; vitreous hemorrhage; certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR); patients who have had a vitrectomy in the study eye at any time
Information: (212) 201-0920 ×277

Study: A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus (RIDE)
Sponsor: Genentech
Status: Currently enrolling
Purpose: To study the efficacy and safety of ranibizumab injection in patients with clinically signficant macular edema-CI secondary to diabetes mellitus (type 1 or 2)
Design: Treatment
Number of Patients: 366
Inclusion Criteria: Age ≥18 years; diabetes mellitus (Type 1 or 2); retinal thickening secondary to diabetes mellitus (DME); BCVA score in the study eye of 20/40 to 20/320; decrease in vision determined to be primarily the result of DME and not to other causes
Exclusion Criteria: History of vitreoretinal surgery in the study eye; panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening; previous use of intraocular corticosteroids in the study eye (eg, TA) within 3 months of screening; previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within 3 months of the day 0 visit; PDR in the study eye, with the exception of inactive, regressed PDR; iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in the study eye; vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is considered by the investigator to significantly affect central vision; ocular inflammation (including trace or above) in the study eye; history of idiopathic or autoimmune uveitis in either eye; structural damage to the center of the macula in the study eye that is likely to preclude improvement in VA following the resolution of macular edema; ocular disorders in the study eye that may confound interpretation of study results; concurrent disease in the study eye that would compromise VA or require medical or surgical intervention during the study period
Information: (888) 662-6728

Study: Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema
Sponsor: Rocky Mountain Retina Consultants/Genentech
Status: Currently enrolling
Purpose: To evaluate the clinical efficacy of intravitreal injections of ranibizumab (Lucentis) in the treatment of diabetic macular edema as compared to grid/focal laser
Design: Treatment, Randomized, Open-label, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 60
Inclusion Criteria: Clinically significant diabetic macular edema (CSME) or clinically significant diabetic macular edema with center involvement (CSME-CI) as defined by the ETDRS Trial (ETDRS Research Group 1987 and 1991); retinal thickening within 500 μm of the center of the fovea; hard exudates within 500 μm of the center of the fovea (if associated with adjacent retinal thickening, which may be outside of 500 μm limit); area of macular edema greater than 1 disc area but within 1 disc diameter of the center of the macula; age >21 years; VA <20/320 with definite retinal thickening due to diabetic macular edema based on clinical exam; retinal thickness on OCT measuring 250 μm or more in the central subfield or 350 μm of more in any noncentral subfield. Media clarity and pupillary dilation, patient cooperation, and adequate fundus photographs and OCT will be obtainable; no other ocular conditions that could cause macular edema will be present
Exclusion Criteria: Intraocular pressures exceed 25 mm Hg; participation in another simultaneous medical investigation or trial or previous trial of Lucentis or Avastin; premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch; current treatment of a systemic infection; evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders; history of recurrent significant infections or bacterial infections; any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period Active intraocular inflammation (grade trace or above) in the study eye Current vitreous hemorrhage in the study eye; history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye; history of idiopathic or autoimmune-associated uveitis in either eye; active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye; concurrent ocular disease associated with choroidal neovascularization to include but not limited to presumed ocular histoplasmosis, high myopia, or macular degeneration
Information: study@rmrc.xohost.com

Study: Combined Approach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study
Sponsor: Johns Hopkins University/Juvenile Diabetes Research Foundation/Genentech
Status: Currently enrolling
Purpose: To continue the study of anti-VEGF therapy in patients with macular edema, and compare it to an anti-inflammatory therapy and a combined anti-VEGF and antiinflammatory
Design: Treatment, Randomized, Open-label, Dose-comparison, Factorial Assignment, Safety/Efficacy Study
Number of Patients: 72
Inclusion Criteria: 18 years of age; diagnosis of diabetes mellitus (type 1 or type 2); serum HbA1c 5.5% within 12 months of randomization; retinal thickening (diabetic macular edema) involving the center of the fovea; diagnosis must be confirmed by FA and OCT images over 250; BCVA score in the study eye of 20/40 to 20/320
Exclusion Criteria: Panretinal or macular photocoagulation within 3 months of study entry in the study eye; use of intraocular or periocular injection of steroids in the study eye within 3 months of study entry; previous participation in a study and receipt of antiangiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry; current or history of prior treatment of psoriasis with subcutaneous efalizumab within 6 months of study entry; proliferative diabetic retinopathy in the study eye
Information: jdenton2@jhmi.edu

Study: Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Sponsor: Novagali Pharma
Status: Currently enrolling
Purpose: To evaluate the safety and efficacy of a single injection of NOVA63035 "Corticosteroid" administered at 1 of 3 doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy
Design: Supportive Care, Non-randomized, Open-label, Single-group Assignment, Safety/Efficacy Study
Number of Patients: 18
Inclusion Criteria: Age ≥18 years old; diagnosed with diabetes mellitus and presenting diabetic retinopathy
Exclusion Criteria: Monocularity; history of current ocular hypertension or glaucoma in either eye defined; any significant ocular disease (other than diabetic retinopathy)
Information: mourad.amrane@novagali.com

Study: Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase 2)
Sponsor: Genentech/Michael J. Jumper, MD
Status: Currently enrolling
Purpose: To study the safety and efficacy of a single dose of intravitreally administered ranibizumab 0.5 mg in subjects with proliferative diabetic retinopathy experiencing post-panretinal photocoagulation (PRP) macular edema
Design: Treatment, Randomized, Open-label, Placebo-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Pre-PRP protocol refraction, fluorescein angiography, and OCT AND 7-14 day post-PRP OCT; previously untreated PDR patients with high-risk characteristics who develop edema within 7 to 14 days post-PRP therapy. This edema, determined by a masked investigator, will be characterized as either increased foveal thickness (>20% increase from pre-PRP foveal thickness), and/or increased macular volume on OCT (>20% increase from pre-PRP macular volume)
Exclusion Criteria: Participation in another simultaneous medical investigation or trial; pre-PRP clinically significant diabetic macular edema (CSME) that would make the patient eligible for macular laser prior to PRP; neovascularization of the iris or neovascular glaucoma; increased central foveal thickness for any other reason; concurrent macular diseases that could confound the results of this study; prior vitrectomy in the study eye; prior treatment with intravitreal injection including pegaptanib sodium, ranibizumab, bevacizumab or triamcinolone acetonide
Information: jrose@westcoastretina.com

Study: Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema
Sponsor: MacuSight, Inc.
Status: Currently enrolling
Purpose: To determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with diabetic macular edema
Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo-control, Single-group Assignment, Safety/Efficacy Study
Number of Patients: 120
Inclusion Criteria: Diagnosis of diabetes mellitus; macular edema secondary to diabetic retinopathy; VA of 20/40 to 20/200 in study eye
Exclusion Criteria: Any other ocular disease in the study eye; any intravitreal injections, posterior subtenons steroids, photocoagulation, or intraocular surgery in study eye within 90 days; capsulotomy of study eye within 30 days
Information: cdelpouys@macusight.com

Study: Intravitreal Infliximab for Diabetic Macular Edema (DME) and Choroidal Neovascularization (CNV) (ITVR)
Sponsor: Retina Research Foundation
Status: Currently enrolling
Purpose: To determine if infliximab injections into the eye are safe
Design: Treatment, Nonrandomized, Open-label, Single-group Assignment, Safety Study
Number of Patients: 4
Inclusion Criteria: Age > 21 years; patients with active CNV secondary to AMD in the study eye that did not improve with conventional therapy; patients with refractory diabetic macular edema in the study eye that did not improve with conventional therapy; BCVA 20/70 or less as measured on an ETDRS chart
Exclusion Criteria: Inability to obtain photographs, fluorescein angiography, or optical coherence tomography to document CNV, eg, due to media opacity, allergy to fluorescein dye or lack of venous access; aphakia or pseudophakia with the absence of posterior capsule (unless it resulted from a yttrium aluminum garner [YAG]) posterior capsulotomy); within 1 month prior to screening had YAG laser in the study eye; have had intravitreal anti-VEGF or intravitreal steroids in the last 6 weeks; have had previous pars plana vitrectomy in the study eye
Information: (518) 533-6550

Study: Sirolimus to Treat Diabetic Macular Edema
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To test whether sirolimus, a drug approved to treat psoriasis and other conditions, can help patients with diabetic macular edema
Design: Treatment, Non-Randomized, Open-label, Uncontrolled, Single-group Assignment, Efficacy Study
Number of Patients: 8
Inclusion Criteria: Documented hemoglobin A1C 12% or less within 1 month of baseline
Exclusion Criteria: History of chronic renal failure requiring dialysis or kidney transplant; ccondition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control). Patients in poor glycemic control who, within the last four months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next four months should not be enrolled; participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry; history of cancer (other than a non-melanoma skin cancer) diagnosed within the past five years that could be worsened by immunosuppression; laboratory values outside normal limits and considered clinically significant by the investigator; blood pressure greater than 180/110 (systolic above 180 OR diastolic above 110); concurrent use of intravitreal anti-VEGF therapy or subtenon/intravitreal steroids in the fellow eye
Information: (800) 411-1222

Study: DEGAS: Prospective, Randomized, Multi-Center, Comparator Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema
Sponsor: Pfizer
Status: Currently enrolling
Purpose: To evaluate the effectiveness of study drug in improving visual acuity compared to laser treatment in the patients with diabetic macular edema
Design: Treatment, Randomized, Single-blind (Subject), Parallel Assignment, Safety/Efficacy Study
Number of Patients: 160
Inclusion Criteria: Patients with diabetes mellitus (either type 1 or type 2) showing diabetic macular edema
Exclusion Criteria: Proliferative diabetic retinopathy in the study eye; receiving concomitant intravitreal anti-vascular endothelial growth factor (VEGF) therapy
Information: (800) 718-1021

RETINAL VEIN OCCLUSION
Study: RAVE: Rubeosis Anti-VEGF Trial for Ischemic Central Retinal Vein Occlusion
Sponsor: Greater Houston Retina Research
Status: Enrolling patients
Purpose: To see if total VEGF blockade will prevent neovascular glaucoma and eliminate the need for panretinal photocoagulation in patients with ischemic CRVO
Design: Treatment, Randomized, Open-label, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Ischemic CRVO within 3 months of enrollment as per the following inclusion Criteria: VA 20/200 or worse; RAPD 0.9 LU or worse; loss of 1-2e isopter on Goldmann visual field; ERG demonstrating B-wave amplitude less than 60% of A wave
Exclusion Criteria: Angle neovascularization >3 clock hours with IOP over 30 (neovascular glaucoma); any previous retinal laser photocoagulation to the study eye, any previous intravitreal injection in study eye (triamcinolone or other), or any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery); intracapsular cataract extraction (posterior capsule needs to be present); previous history of retinal detachment in study eye; any previous radiation treatments to head/neck; significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12-month study or significant diabetic retinopathy in the fellow eye (DME, proliferative diabetic retinopathy, or high-risk nonproliferative diabetic retinopathy); pregnancy
Information: (713) 524-3434

Study: CRUISE: A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion
Sponsor: Genentech
Status: Currently enrolling
Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to CRVO
Design: Treatment
Number of Patients: 390
Inclusion Criteria: Foveal center-involved macular edema secondary to CRVO; BCVA using ETDRS charts of 20/50 to 20/320 (Snellen equivalent) in the study eye; mean central subfield thickness ≥250 μm on 2 OCT measurements; media clarity, pupillary dilation, and participant cooperation sufficient for adequate fundus photographs
Exclusion Criteria: History of cerebral vascular accident or myocardial infarction within 3 months prior to day 0; history of any anti-VEGF treatment in fellow eye within 3 months prior to day 0; history of allergy to fluorescein not amenable to treatment; history of allergy to ranibizumab injection or related molecule; relevant systemic disease that may be associated with increased systemic VEGF levels
Information: (888) 662-6728

Study: BRAVO: Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion
Sponsor: Genentech
Status: Currently enrolling
Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to BRVO
Design: Treatment
Number of Patients: 390
Inclusion Criteria: Foveal center-involved macular edema secondary to BRVO; BCVA using ETDRS charts of 20/50 to 20/320 (Snellen equivalent) in the study eye; mean central subfield thickness ≥250 μm on 2 OCT measurements; media clarity, pupillary dilation, and participant cooperation sufficient for adequate fundus photographs
Exclusion Criteria: History of cerebral vascular accident or myocardial infarction within 3 months prior to day 0; history of any anti-VEGF treatment in fellow eye within 3 months prior to day 0; history of allergy to fluorescein not amenable to treatment; history of allergy to ranibizumab injection or related molecule; relevant systemic disease that may be associated with increased systemic VEGF levels
Information: (888) 662-6728

Study: Effectiveness and Safety of Niacin and a Topical Steroid to Treat Retinal Vein Occlusions
Sponsor: Palo Alto Medical Foundation
Status: Currently enrolling
Purpose: To determine whether niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye
Design: Treatment, Nonrandomized, Open-label, Active-control, Single-group Assignment, Safety/Efficacy Study
Number of Patients: 68
Inclusion Criteria: Patient must have central retinal vein occlusion, hemiretinal vein occlusion or branch retinal vein occlusion
Exclusion Criteria: Active gout or high levels of uric acid
Information: gaynonM@pamf.org

Study: Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion
Sponsor: Palmetto Retina Center, LLC; Pfizer; OSI Pharmaceuticals
Status: Currently enrolling
Purpose: Study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO)
Design: Treatment, Randomized, Open-label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Macular edema secondary to BRVO involving the foveal center in male or female patients at least 18 years of age; duration of BRVO macular edema less than 6 months prior to baseline visit; best corrected ETDRS VA 20/40 to 20/320 (Snellen equivalent) using the 4 meters testing method; central foveal thickness greater than or equal to 250 μm using the OCT-3; <25% of foveal capillary ring disruption; <2 disc areas of capillary nonperfusion within 1000 μm of the foveal center; absence of hemorrhage or lipid in the foveal center
Exclusion Criteria: Ocular conditions other than BRVO-related macular edema such as significant cataract, diabetic retinopathy, AMD, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or tumor; intraocular surgery within past 3 months; significant enlargement of foveal avascular zone(>25% disruption of capillary ring) or greater than 2 disc areas of nonperfusion within 1000 μm of foveal center; likelihood of evidence-driven indication for peripheral photocoagulation in the next 6 months; patients who have shown evidence of spontaneous improvement within the preceding 3 months, as determined by an improvement of >15 letters of vision or thinning of the Center Point on OCT of >20% from baseline determination; prior grid laser within 4 months of baseline or more than 1 prior grid laser treatment; no prior intravitreous or periocular steroid injections in the study eye
Information: jackwells@palmettoretina.com

Study: Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)
Sponsor: Duke University; Bausch & Lomb
Status: Currently enrolling
Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of retinal vein occlusion that has caused persistent macular edema and decreased visual acuity
Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single-group Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: A history of retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and OCT; macular edema at least 1 disc area in size that involved the fovea; males and nonpregnant females at least 18 years of age; IOP controlled at <21 mm Hg with no more than one topical ocular antihypertensive agent; initially, patients with vein occlusion were not required to have previous therapy. However, the protocol was subsequently modified to require an intravitreal injection of triamcinolone acetonide >12 weeks prior to study entry, with an initial decrease in macular edema and improvement in VA and subsequent decline in VA accompanied by increased macular edema. This modification was added to avoid enrolling patients who might have had a longlasting response to a single intravitreal triamcinolone acetonide injection
Exclusion Criteria: Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation, or media opacity precluding evaluation of study eye status; patients with disciform scars of the fovea or atrophic changes of the macula that in the investigator's opinion would preclude benefit from treatment are excluded from the study; female patients who were pregnant or lactating or not taking precautions to avoid pregnancy
Information: (919) 684-4458

Study: Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema
Sponsor: Vitreous-Retina Macula Consultants of New York/Genentech
Status: Enrolling patients
Purpose: To examine the effects of Lucentis for active Central Retinal Vein Occlusion with Macular Edema
Design: Treatment, Non-randomized, Open-label, Active-control, Single-group Assignment, Safety Study
Number of Patients: 45
Inclusion Criteria: Age >18 years; clinical evidence of perfused central retinal vein occlusion. A central retinal vein occlusion (CRVO) is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head; central macular edema present on clinical examination and OCT testing with a central point thickness >250 μm; visual acuity score greater than or equal to 34 letters (20/200) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol; media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
Exclusion Critieria: Participation in another simultaneous ocular investigation or trial; uncontrolled hypertension; a condition that, in the opinion of the investigator would preclude participation in the study (i.e. chronic alcoholism, drug abuse); significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy; exam or OCT reveals evidence of vitreoretinal interface abnormality that may be contributing to the macular edema; eye that in the investigator has no chance of improvement in visual acuity following resolution of macular edema (ie, subretinal fibrosis or geographic atrophy); any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy (AION), age related macular degeneration (AMD), retinal detachment, severe cataracts, etc.
Information: (212) 452-6965

COMPLETED ENROLLMENT
Study: Screening for Studies on Inherited Eye Diseases
Sponsor: National Eye Institute
Information: (800) 411-1222

Study: Study of the Repeat Dosing of Ketoconazole on the Pharmacokinetics of a Single Dose Of Pazopanib (GW786034) Eye Drops
Sponsor: GlaxoSmithKline
Information: (877) 379-3718

Study: Age-Related Eye Disease Study II (AREDS II)
Sponsor: National Eye Institute
Information: http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120

Study: Evaluation and Treatment of Patients with Retinal Disease
Sponsor: National Eye Institute
Contact: (800) 411-1222

Study: Screening for Studies on Retinovascular Diseases
Sponsor: National Eye Institute
Contact: (800) 411-1222

Study: Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Sponsor: Diabetic Retinopathy Clinical Research Network
Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolJ_lrtpdr/ProtJInfo.html

Study: LUMINATE: A Study of LX211 in Active Sight-Threatening, Noninfectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
Sponsor: Lux Biosciences, Inc.
Information: clinicaltrials@luxbio.com

Study: Phase 2 Study of MM-093 to Treat Patients With Uveitis
Sponsor: Merrimack Pharmaceuticals
Information: (617) 441-1000

COMPLETED TRIALS
Study: A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin)
Sponsor: Diabetic Retinopathy Clinical Research Network
Results: http://public.drcr.net/DRCR netstudies/studies/ProtocolH_antivegf/ProtHInfo.html


Retinal Physician, Issue: September 2008