Article Date: 10/1/2007

CLINICAL TRIAL UPDATE

CLINICAL TRIAL UPDATE

DRY AMD

Study: Age-Related Eye Disease Study II (AREDS II)
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: Investigate the effects of oral supplements of lutein/zeaxanthin and omega-3 fatty acids for the treatment of AMD. A secondary randomization will further refine the AREDS-type supplement by testing a lower dose of zinc and eliminating beta-carotene
Design: Phase 3, randomized, prospective, multicenter trial
Number of Patients: 4000
Number of Clinical Centers: 80 plus
Inclusion Criteria: Age 55 years to 80 years; bilateral large drusen (>125 μm) or advanced AMD (neovascular AMD or geographic atrophy involving the center of fovea) in 1 eye only and presence of large drusen in the fellow eye
Exclusion Criteria: Choroidal neovascularization (CNV) associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, other confounding ocular disease or surgical procedures (except for cataract surgery or YAG laser)
Information: http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120

Study: Measuring Reading Rehabilitation Outcomes
Sponsor: Department of Veteran 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; choroidal neovascularization ("wet" AMD); moderate to severe media opacities; and cognitive impairment
Information: (312) 996-1466

Study: Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry AMD
Sponsor: Sirion
Status: Currently enrolling
Purpose: To determine the efficacy of fenretinide in the treatment of geographic atrophy in subjects with the dry form of AMD
Design: Multicenter, randomized, double-masked, placebo-controlled, dose comparison
Number of Patients: 225
Inclusion Criteria: Age from 50-89 years old; must have geographic atrophy from AMD in 1 or both eyes
Exclusion Criteria: Geographic atrophy due to any disease other than AMD
Contact: (813) 496-7325 ×300 or clinical.trials@siriontherapeutics.com

Study: RHEO-AMD
Sponsor: Occulogix
Status: Enrolling patients
Purpose: To evaluate rheopheresis treatment for dry AMD
Design: Multi-center, prospective, randomized, double-masked study comparing safety and efficacy
Number of Patients: 325
Inclusion Criteria: Subjects 50-85 yrs and 50-100 kg; baseline study eye ETDRS BCVA 20/40-20/100 (Snellen equivalent); and, diagnosis of dry AMD in study eye with ≥3 soft, semi-soft, or confluent drusen ≥125 μm within 3,000 μm of foveal center (total equivalent drusen surface area ≥31,000 μm2)
Exclusion Criteria: Previous or active CNV; geographic atrophy (GA) within 500 μm of foveal center; GA ≥250 μm in diameter; serous (non-drusenoid) pigment epithelium detachment; nongeographic hypopigmentation within 500 μm of foveal center; or, significant opacities causing vision decrease or limiting view of fundus
Information: http://www.occulogix.com/

Study: A Study of an Encapsulated Cell Technology (ECT) Implant for Patients With Atrophic Macular Degeneration
Sponsor: Neurotech Pharmaceuticals
Status: Enrolling patients
Purpose: To look at the safety and effectiveness of CNTF implants on vision in participants with atrophic macular degeneration.
Study Design: Treatment, Randomized, Double-Blind, Dose-Comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 48
Inclusion Criteria: ≥50 years old; diagnosis of AMD with the presence of geographic atrophy; VA no better than 20/63 and no worse than 20/160; history of recent visual acuity loss
Exclusion Criteria: Pregnancy; conversion of AMD to "wet" form; other eye diseases including advanced cataract; chronic systemic disease requiring continuous treatment with systemic steroids, immuno-suppressive medications or insulin
Information: clinicalcontact@neurotechusa.com

Study: OMEGA: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration
Sponsor: Othera Pharmaceuticals
Status: Enrolling patients
Purpose: To compare the ability of 2 doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively treat geographic atrophy associated with AMD
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 200
Inclusion Criteria: Must have a clinical diagnosis of GA in 1 or both eyes; must be of nonchildbearing potential
Exclusion Criteria: GA secondary to any condition other than AMD in the study eye; BCVA of 20/200 or worse in nonstudy eye; history of CNV in either eye; need for contact lenses in study eye
Information: clinicaltrials@othera.com

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 est a new method for preventing worsening of AMD and for developing imaging methods to follow the very earliest microscopic changes in the disease.
Study 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 our bicolor sunglasses whenever outdoors in daylight and to keep a log book of use and to return periodically to NIH for our noninvasive imaging studies.
Exclusion Criteria: Wet AMD; prior eye disorders; diabetes or current chemotherapy
Information: (800) 411-1222

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, non-randomized, 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 Retinal 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 choroidal neovascularization
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 73-24 (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 other causes 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 (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography [FA], hot spot on static ICG, visible RAP lesion of 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 non-study eye less than 7 days preceding Day 0; previous participation in a clinical trial (for either eye) involving anti angiogenic 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: Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
Sponsor: Johns Hopkins University/Genentech
Status: Enrolling patients
Purpose: To look at the effects of ranibizumab on a condition called "predominantly hemorrhagic subfoveal CNV due to wet AMD
Number of Patients: 10
Inclusion Criteria: Age >50 years old; must have media clear enough to permit fundus photography, FA, and optical coherence tomography (OCT)
Exclusion Criteria: Known hypersensitivity to humanized monoclonal antibodies; history (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment); history of stroke within 6 months of study entry; current acute ocular or periocular infection; any major surgical procedure within 1 month of study entry; known serious allergies to fluorescein dye
Contact: (443) 257-9692

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; visual acuity 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: A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
Sponsor: Allergan
Status: Currently enrolling
Purpose: To evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal CNV associated with AMD
Design: Treatment, Randomized, Single-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 135
Inclusion Criteria: ≥50 years with "wet" AMD as determined by an ophthalmologist; decrease in VA (20/40 to 20/400) in at least 1 eye
Exclusion Criteria: Uncontrolled systemic disease; history of heart attack or stroke within 1 year of study entry; symptomatic coronary artery disease; cataracts that interfere with vision
Information: clinicaltrials@allergan.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 AND
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
Study Design: Treatment, Non-Randomized, 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 Name: 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
Study Design: Treatment, Randomized, Open-Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Inclusion Criteria: Treatment-naïve patients with active, subfoveal, exudative AMD; visual acuity of 20/40-20/320 in the study eye; subfoveal CNV must be at least 50% of the total lesion size; total area of lesion components other that CNV must be less than 50% of the total lesion size; lesion must be <5400 μm in greatest linear dimension (GLD); lesion size <10 disc areas (DAs)
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; intraocular pressure 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: TAPER: Second-line Therapy to Treat AMD for Patients Not Responding Well to Lucentis Therapy by Itself
Sponsor: Vitreous Retina Macula Consultants of New York/QLT Inc.
Status: Enrolling patients
Purpose: To demonstrate that Visudyne-Lucentis-Dexamethasone triple therapy will give similar efficacy and safety results as Lucentis monotherapy
Study Design: Randomized, Masked, Efficacy Study
Inclusion Criteria: Patients with subfoveal CNV due to AMD who, after 2 to 6 previous treatments with Lucentis monotherapy, continue to have exudative activity associated with the CNV lesion 4 to 8 weeks after the last treatment; all lesion composition types with a lesion GLD ≥5400 μm (approximately ≥9 DA); BCVA score of 25 to 73 letters (approximate Snellen equivalent of 20/40 to 20/320)
Exclusion Criteria: Subfoveal geographic atrophy or subfoveal fibrosis in the study eye; intraocular surgery within 3 months of enrollment
Information: (604) 742-1025

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.
Study Design: Prospective, uncontrolled, non-randomized, 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 mm 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 diabetic macular edema (DME), severe nonproliferative 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 enrolment; 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, end stage 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
Study Design: Treatment, Non-Randomized, 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; visual acuity 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: TAC-PF, Avastin in Combination With Photodynamic Therapy to Treat AMD
Sponsor: NEI/QLT, Inc.
Status: Currently enrolling
Purpose: To investigate whether a triple therapy, Avastin, half-fluence verteporfin PDT, and triamcinolone acetonide-preservative free (TAC-PF), results in improved 12-month vision outcome compared to Avastin alone in participants with wet AMD
Study Design: Treatment, Randomized, Single-Blind, Active Control, Parallel Assignment, Efficacy Study
Number of Patients: 100
Inclusion Criteria: Drusen >63 mm; CNV under the fovea (predominantly classic, minimally classic, and occult lesions acceptable); greatest linear dimension (GLD) of entire lesion <5400 μm (no reading center confirmation required); ETDRS best corrected visual acuity of 20/40-20/320 (73-24 letter score); total area of lesion must be <9 MPS DA
Exclusion Criteria: Oral steroid use in last 6 months; prior stroke or myocardial infarction; geographic atrophy or fibrosis under the fovea; fibrosis, hemorrhage, pigment epithelial detachments and other hypofluorescent lesions obscuring more than 50% of total lesion; prior treatment with verteporfin or ocular anti-VEGF; IOP >25 mm Hg and the participant is on Cosopt; intraocular surgery within 6 weeks; any prior intravitreal drug delivery; prior vitrectomy; peribulbar steroid injection within 6 months; poor reactions to topical or periocular steroid treatment including elevated IOP
Information: (865) 588-0811

Study: CABERNET: Study of Strontium90 Beta Radiation With Lucentis to Treat AMD
Sponsor: NeoVista
Status: Enrolling patients
Purpose: To evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD).
Study 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 anti-angiogenic or intravitreal antiangiogenic agents in study eye; previous radiation therapy to the eye, head, or neck; diagnosis of diabetes
Information: (816) 404-1815

Study: Open-Label, Pilot Study of TG100801 in Patients With Choroidal Neovascularization Due to AMD
Sponsor: TargeGen
Status: Enrolling patients
Purpose: To evaluate the ability of topical administration of TG100801 to reduce the amount of fluid in the retina in patients with AMD following 30 days of treatment
Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 40
Inclusion Criteria: Subfoveal CNV secondary to AMD; CNV lesion size less than or equal to 12 MPS disk area; CNV >50% of lesion area; presence of intraretinal fluid causing an increase in central subfield thickness of at least 300 μm, confirmed by OCT in study eye; any lesion composition; BCVA of 20/40 to 20/320 (73 to 24 ETDRS letters) at 4 m in study eye; BCVA of 20/800 or better (at least 4 ETDRS letters) at 4 m infellow eye
Exclusion Criteria: RPE rip or tear in study eye; blood >1 disk area, atrophy, or fibrosis (disciform scar) under foveal center of study eye; scarring/fibrosis of at least 25% of total CNV lesion in study eye; hemorrhage or PED >50% of total CNV lesion in study eye; glaucoma with visual field loss or IOP at least 25 mm Hg in study eye or consistently at least 25 mm Hg in fellow eye
Information: shorr@targegen.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 pre-treatment 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
Study 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 best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen equivalent)
Exclusion Criteria: Any intraocular surgery of the study eye within12 weeks of screening; previous posterior vitrectomy of the study eye; advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment
Information: clinicaltrials@opko.com

Study: RADICAL: Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions
Sponsor: QLT, Inc.
Status: Currently enrolling
Purpose: To determine if combination therapy (reduced-fluence Visudyne followed by Lucentis [within 2 hours] or either of 2 regimens of reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy [within 2 hours]) reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 160
Inclusion Criteria: Treatment-naive for choroidal neovascularization (CNV) secondary to AMD in the study eye; subfoveal CNV due to AMD; CNV must be ≥50 % of the entire lesion; all lesion composition types with a lesion greatest linear dimension (GLD) <5400 μm (approximately ≤9 disc areas [DA]); BCVA ETDRS score of 25 to 73 letters (approximate Snellen equivalent of 20/40 to 20/320), inclusive
Exclusion Criteria: Subfoveal geographic atrophy or subfoveal fibrosis of the study eye; intraocular surgery within 3 months of enrollment
Information: (604) 707-7000

Study: 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
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Inclusion Criteria: Age >50 years; women must be postmenopausal without a period for at least one 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 subtenon'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 age-related macular degeneration.
Study 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

SCREENING

Study: Evaluation and Treatment of Patients with Retinal Disease
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To allow National Eye Institute physicians to increase their knowledge of retinal eye diseases and identify possible new avenues of research in this area
Design: Natural history
Number of Patients: 500
Inclusion Criteria: Diagnosis of AMD
Exclusion Criteria: Inability to be followed for 3 years
Contact: (800) 411-1222

Study: Screening for Studies on Retinovascular Diseases
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To help recruit patients for National Eye Institute (NEI) studies of the retina
Design: Natural history
Number of Patients: 1500
Inclusion and Exclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. In addition to those diagnoses currently under study, subjects with unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study; all studies of retinovascular diseases require the subject to have minimum age of 18 years in both men and women
Contact: (800) 411-1222

Study: Genetic Factors in AMD
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To examine whether certain polymorphisms predispose people to develop AMD
Design: Screening
Number of Patients: 400
Inclusion Criteria: (AMD patients) Age ≥50 years; diagnosis of advanced AMD defined by geographic atrophy and/or CNV with drusen of any size in at least 1 eye; (Control patients) Age >70 years; absence of drusen or no more than 5 drusen <63 μm; absence of other diagnostic criteria for AMD
Exclusion Criteria: Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases that have been present prior to the age of 50; opacities of the ocular media; limitations of papillary dilation or other problems sufficient to preclude adequate stereo fundus photography (occluded pupils due to synechia, cataracts, vitreous haze, and opacities due to ocular diseases)
Information: (800) 411-1222

Study: Investigating Age-Related Macular Degeneration
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To examine an Amish community to investigate genetic factors in the development of AMD
Design: Natural history
Number of Patients: 1000
Inclusion Criteria: All Amish individuals, ≥50 years
Information: (301) 496-6583

Study: Ultrasonic Evaluation of Ocular Tissues
Sponsor: Weill Medical College of Cornell University/Riverside Research Institute
Status: Currently enrolling
Purpose: To improve diagnosis and treatment monitoring of ophthalmic disease by improving diagnostic ultrasound techniques
Design: Screening, Cross-Sectional, Defined-Population, Retrospective/Prospective Study
Number of Patients: 150
Inclusion Criteria: Have one of the following eye diseases: Glaucoma, ocular tumors, AMD
Information: (212) 746-6106

Study: Screening for Studies on Inherited Eye Diseases
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To help recruit patients for National Eye Institute (NEI) studies on inherited eye diseases
Design: Natural History
Number of Patients: 800
Inclusion/Exclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. in addition to those diagnoses currently under study, subjects with unusual, interesting, or unknown conditions that require the establishment of a diagnosis, may be eligible for inclusion in this study
Information: (800) 411-1222

RETINAL IMAGING STUDIES

Study: Retinal Imaging in Patients With Inherited Retinal Degenerations Sponsor: University of California-San Francisco/University of California-Berkeley
Status: Enrolling patients
Purpose: To determine whether the structure and function of the human retina can be studied with high resolution in patients with inherited retinal degenerations using the Adaptive Optics Scanning Laser Ophthalmoscope
Design: Natural History, Longitudinal, Defined Population, Prospective Study
Number of Patients: 130
Inclusion Criteria: Subjects must have pupils that dilate to at least 6 mm diameter and must be willing to travel to UC Berkeley
Exclusion Criteria: Cataract; irregular corneal astigmatism (keratoconus); prior refractive surgery
Information: Jacque L. Duncan, MD, (415) 514-4241, duncanj@vision.ucsf.edu

Study: Novel Diagnostics for Ocular Structure
Sponsor: University of Pittsburgh/National Institutes of Health
Status: Enrolling patients
Purpose: To evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called OCT
Design: Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
Number of Patients: 500
Inclusion Criteria: Diagnosis of macular degeneration, diabetic retinopathy, and/or glaucoma
Exclusion Criteria: Media opacity (lens, vitreous, cornea); diagnosis of strabismus, nystagmus, or a condition that would prevent fixation
Information: Tammy J Capozzoli, (412) 647-2375, capozzolitj@upmc.edu

Study: Novel Diagnostics With Optical Coherence Tomography: Retinal Imaging
Sponsor: University of Pittsburgh
Status: Currently enrolling
Purpose: To evaluate OCT and FDA-approved device used to image diseases of the eye
Design: Screening, Longitudinal, Convenience Sample, Retrospective/Prospective Study
Number of Patients: 1500
Inclusion Criteria: Subjects with healthy eyes, macular degeneration, glaucoma and various other eye diseases. Also must be able to fixate on target.
Exclusion Criteria: Fundus not visible or opaque media
Information: (412) 647-2375

DIABETIC MACULAR EDEMA

Study: FAME (Fluocinolone Acetonide in Macular Edema)
Sponsor: Alimera Sciences & Controlled Delivery Systems
Number of Sites: Approximately 100
Number of Patients: More than 900
Status: Phase 3 initiated
Purpose: To evaluate the safety and efficacy of sustained-release fluocinolone acetonide, at 2 doses, delivered via the Medidur intraocular sustained delivery system
Design: Double-masked, randomized, multicenter, parallel group, controlled study
Inclusion/Exclusion Criteria: Patients diagnosed with DME, who have previously had laser treatment
Information: www.alimerasciences.com

Study: Reduction in the Occurrence of Center-threatening DME
Sponsor: Eli Lilly and Company
Status: Enrolling patients
Purpose: Determine whether ruboxistaurin can slow the progression of DME
Design: Randomization 1:1, ruboxistaurin/placebo
Inclusion Criteria: Type 1 or type 2 diabetes; >18 years; nonclinically significant DME; mild to moderate diabetic retinopathy in the study eye or vitreous hemorrhage in the study eye; relatively good vision (20/30 or better)
Exclusion Criteria: Surgery or laser treatment in the study eye; glaucoma in the study eye; HbA1c >11%, or systolic blood pressure <170 mm Hg
Information: (877) 285-4559

Study: Safety and Tolerability of MS-R001 in Patients With DME Secondary to Diabetic Retinopathy
Sponsor: MacuSight
Status: Currently enrolling
Purpose: To determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy
Study Design: Randomized, Open-Label, Dose-Comparison, Single Group Assignment, Safety Study
Number of Patients: 30
Inclusion Criteria: Diagnosis diabetes mellitus; VA of 20/40 to 20/200 instudy eye
Exclusion Criteria: Any other ocular disease that could compromise vision in the study eye; intraocular surgery of the study eye within 90 days prior to study start; capsulotomy of the study eye within 30 days prior to study start
Information: (602) 222-2221 or (817) 749-0180

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 diabetic macular edema
Study 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); visual acuity in 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
Study 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: Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema
Sponsor: Diabetic Retinopathy Clinical Research Network
Status: Currently enrolling
Purpose: To determine if ranibizumab alone or ranibizumab added to laser photocoagulation is more efficacious than photocoagulation alone, and if so, to determine if combining ranibizumab with photocoagulation reduces the total number of injections needed to obtain these benefits
Study Design: Randomized, Multicenter Clinical Trial
Number of Patients: 700
Inclusion Criteria: Age ≥18 years; type 1 or type 2 diabetes; DME involving the center of the macula (OCT central subfield thickness >250 μm) responsible for VA of 20/32 or worse
Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolI_lrtdme/ProtIInfo.html

Study: Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Sponsor: Diabetic Retinopathy Clinical Research Network
Status: Currently enrolling
Purpose: To determine whether intravitreal injection of an anti-VEGF drug or an intravitreal injection of a corticosteroid can reduce the risk of VA impairment that can occur following PRP and increase the chances of at least short-term VA improvement in eyes with evidence of center-involved macular edema that are undergoing PRP for PDR
Study Design: Prospective, Multicenter Randomized Clinical Trial
Number of Patients: 380
Inclusion Criteria: Age ≥18 years; type 1 or type 2 diabetes; study eye with proliferative diabetic retinopathy for which the investigator intends to perform full-scatter photocoagulation; DME involving the center of the macula (OCT central subfield thickness >250 μm) and reducing VA to 20/32 or worse
Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolJ_lrtpdr/ProtJInfo.html

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
Study 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 non-proliferative 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
Study 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: Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser
Sponsor: Ophthalmic Consultants of Boston/ISTA Pharmaceuticals
Status: Currently enrolling
Purpose: To assess the safety and biologic activity of bromfenac in subjects with diffuse DME refractory to laser
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 10
Inclusion Criteria: Age ≥18 years old; center-involved macular edema secondary to diabetes mellitus
Exclusion Criteria: Study eye with edema amenable to focal laser; treatment with laser, intraocular steroids, and anti-VEGF agents within 90 days; current eye infections
Information: prpl@mail.cc.nih.gov

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)
Study Design: Treatment
Number of Patients: 366
Inclusion Criteria: Retinal thickening secondary to diabetes mellitus (DME) involving the center of the fovea with central macularthickness >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 to 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 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: Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
Sponsor: Alimera Sciences
Status: Currently enrolling
Purpose: To evaluate the pharmacokinetics, safety, and efficacy of anintravitreal insert of fluocinolone acetonide for the treatment of diabeticmacular edema
Study Design: Randomized, Open Label, Dose Comparison, Parallel Assignment,Pharmacokinetics Study
Inclusion Criteria: Age ≥18 years with diabetic macular edema; diagnosis of diabetes mellitus types 1 or 2; BCVA of 19 letters; retinal thickness >250 μm by OCT
Exclusion Criteria: Glaucoma, ocular hypertension, IOP >21 mm Hg or concurrent therapy at screening with IOP-lowering agents; retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy; prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months; prior intravitreal or subtenon anti-VEGF therapy within the last 2 months; any ocular surgery or retinal laser treatment within the last 3 months
Information: ghafiz@jhmi.edu

Study: Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
Sponsor: Alimera Sciences
Status: Currently enrolling
Purpose: To evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
Study Design: Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Inclusion Criteria: Age ≥18 years with diabetic macular edema; diagnosis of diabetes mellitus types 1 or 2; BCVA ≥19 letters; retinal thickness > 250 μm by OCT
Exclusion Criteria: Glaucoma, ocular hypertension, IOP >21 mm Hg or concurrent therapy at screening with IOP lowering agents; retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy; prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months; prior intravitreal or subtenon anti-VEGF therapy within the last 2 months
Information: ghafiz@jhmi.edu

RETINAL VEIN OCCLUSION

Study: The Standard Care vs COrticosteroid for REtinal Vein Occlusion (SCORE) Study
Sponsor: National Eye Institute/National Institutes of Health/Department of Health and Human Services
Status: Enrollment began in October 2004
Purpose: To compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with CRVO and BRVO
Design: Multicenter, randomized,phase 3 trial. Eligible patients within each of these 2 disease entities are randomized in a 1:1:1 ratio to 1 of 3 groups: standard care, intravitreal injection(s) of 4 mg of triamcinolone acetonide, or intravitreal injection(s) of 1 mg of triamcinolone acetonide. Enrolled patients are followed for 3 years. The preparation of triamcinolone acetonide used in the study is specially made for injection into the eye and does not contain any preservatives
Inclusion/Exclusion Criteria: Participants with macular edema associated with CRVO and BRVO ≥18 years of age and are willing to provide consent. Detailed inclusion/exclusion criteria are available on the SCORE Web site at http://spitfire.emmes.com/study/score
Number of Patients: 1260; 630 with CRVO and 630 with BRVO
Site(s): 27
Information: (301) 251-1161

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
Study 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 of1-2e isopter on Goldmann Visual field; ERG demonstrating B-wave amplitude less than 60% of A wave
Exclusion Criteria: Angle neovascularization greater than 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: Lucentis for Central Retinal Vein Occlusion (CRVO)
Sponsor: California Retina Consultants/Genentech
Status: Enrolling patients
Purpose: To determine whether ranibizumab will be effective in reducing if not eliminating the macular edema associated with the disease, CRVO
Study Design: Treatment, Randomized, Open-Label, Dose-Comparison, Crossover Assignment, Safety/Efficacy Study
Number of Patients: Contact company
Inclusion Criteria: Age >18 years; clinical evidence of perfused CRVO, defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants; central macular edema present on clinical examination and OCT testing with a central point thickness >250 μm; VA score greater than or equal to 19 letters (20/400) 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 Criteria: Pregnant women or premenopausal women not using adequate contraception; uncontrolled hypertension; significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy; evidence of vitreoretinal interface abnormality that may be contributing to the macular edema; presence of another ocular condition that may affect the VA or macular edema during the course of the study; evidence of neovascularization of the iris or retina (presence of ischemic CRVO); presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study; history of grid/focal laser or Panretinal laser in the study eye; history of vitreous surgery in the study eye; history of use of intravitreal, peribulbar, or retrobulbar steroids within 6 months of the study; history of cataract surgery within 6 months of enrollment; history of YAG capsulotomy within 2 months of the surgery; visual acuity <20/400 in the fellow eye; uncontrolled glaucoma
Information: (805) 963-1648 ×26

Study: A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Sponsor: Allergan
Status: Enrolling patients
Purpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion
Design: Treatment, Randomized, Double-Blind, Dose-Comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 650
Inclusion Criteria: ≥18 years of age or older with macular edema resulting from retinal vein occlusion; decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse); VA in 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; diabetic retinopathy; uncontrolled systemic disease; known steroid-responder; use of systemic steroids or warfarin/heparin
Information: clinicaltrials@allgeran.com

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
Study 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
Study 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 Eye Drop 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.
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 68
Inclusion Criteria: Patient must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion
Exclusion Criteria: Active gout or high levels of uric acid
Information: gaynonM@pamf.org

UVEITIS

Study: LUMINATE: A Study of LX211 in Active Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
Sponsor: Lux Biosciences, Inc.
Status: Currently enrolling
Purpose: To evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious uveitis
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 210
Inclusion Criteria: Documented history of non-infectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis; currently uncontrolled uveitis for a minimum of 2 weeks despite prednisone monotherapy at a dose of ≥10 mg/day (or equivalent) or ≥2 injections of corticosteroid (intravitreal or periocular) within the past 6 months or subjects for whom oral corticosteroid is contraindicated; grade of 2+ or higher for vitreous haze at time of enrollment; considered by the investigator to require corticosteroid-sparing therapy; not planning to undergo elective ocular surgery during the study
Exclusion Criteria: Uveitis of infectious etiology; clinically suspected or confirmed central nervous system or ocular lymphoma; primary diagnosis of anterior uveitis
Information: clinicaltrials@luxbio.com

Study: MUST: Multicenter Uveitis Steroid Treatment
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis, or panuveitis.
Study Design: Treatment, Randomized, Open-Label, Active Control, Parallel Assignment, Efficacy Study
Number of Patients: 400
Inclusion Criteria: Age ≥18; Best-corrected visual acuity of 20/200 in at least1 eye with severe uveitis; intraocular pressure 24 mm Hg or less in all eyes with severe uveitis; media clarity sufficient to allow visualization and imaging of the fundus in at least 1 eye with severe uveitis
Exclusion Criteria: Inadequately controlled diabetes; uncontrolled glaucoma or glaucoma requiring more than 1 anti-glaucoma medication in 1 or more eyes with severe uveitis; advanced glaucomatous optic nerve injury; history of scleritis; presence of an ocular toxoplasmosis scar; HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated
Information: (301) 451-2020

Study: SITE: Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To evaluate whether therapy that suppresses the immune system given to treat inflammatory diseases of the eye is associated with a greater risk of death and of cancer
Study Design: Natural history
Number of Patients: 6300
Exclusion Criteria: No ocular inflammatory disease; infectious ocular inflammatory disease (eg, toxoplasmic retinitis, endophthalmitis, viral retinitis), unless the infectious uveitis followed treatment for a non-infectious ocular inflammatory disease
Information: (800) 411-1222

Study: Immune Responses to Antigens in Non-Infectious Eye Inflammatory Diseases
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To analyze blood samples or substances that may provide a better understanding of the nature of these disorders, possibly leading to improved treatments
Study Design: Natural history
Number of Patients: 200
Inclusion Criteria: Patients ≥6 years old with a diagnosis of ocular inflammatory disease
Information: (800) 411-1222

Study: Study of Difluprednate in the Treatment of Uveitis
Sponsor: Sirion Therapeutics
Status: Currently enrolling
Purpose: To determine the safety and efficacy of difluprednate compared withprednisolone acetate in the treatment of endogenous anterior uveitis
Design: Multicenter, randomized, double-masked, parallel-group,active-controlled
Number of Patients: 90
Inclusion Criteria: Age ≥2 years or older; Diagnosis of endogenous anterioruveitis in at least 1 eye
Exclusion Criteria: Presence of intermediate uveitis, posterior uveitis, orpanuveitis; corneal abrasion or ulceration; any confirmed or suspectedactive viral, bacterial, or fungal keratoconjunctival disease; allergy tosimilar drugs, such as other corticosteroids
Contact: (813) 496-7325 ×300 or clinical.trials@siriontherapeutics.com

OTHER

Study: Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration
Sponsor: Ophthalmic Consultants of Boston/Genentech
Status: Currently enrolling
Purpose: To determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other than wet macular degeneration
Study Design: Treatment, Randomized, Single-Blind, Dose Comparison, Factorial Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Active CNV
Exclusion Criteria: Pregnancy, agerelated macular degeneration, current eye infection or recent eye surgery, participating in other eye studies
Information: (617) 573-1021

COMPLETED ENROLLMENT

Study: AMD DOC Study (Age-Related Macular Degeneration: Detection of Onset of New Choroidal Neovascularization)
Sponsor: Johns Hopkins University
Information: (410) 955-3648

Study: Safety and Efficacy of Repeated Intravitreal Administration of VEGF Trap in Patients with Wet AMD
Sponsor: Regeneron Pharmaceuticals
Information: VEGF.Trap@regeneron.com

Study: Intravitreal vs Sub-Tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders
Sponsor: National Eye Institute
Information: (800) 411-1222

Study: Safety Study of 16.5mg (3.3%) CGC-11047 Injected Once Every 2 Weeks vs. Once Every 4 Weeks in Patients With CNV Due to Age Related Macular Degeneration
Sponsor: CellGate
Information: http://www.clinicaltrials.gov/ct/show/NCT00446654?order=1

Study: READ-2 (Ranibizumab for Edema of the mAcula in Diabetes)
Sponsor: John Hopkins/Juvenile Diabetes Research Foundation/Genentech
Information: http://www.clinicaltrials.gov/ct/show/NCT00407381?order=1

COMPLETED TRIALS

Study: Temporal Variation in Optical Coherence Tomography Measurements of Retinal Thickening in Diabetic Macular Edema
Sponsor: Diabetic Retinopathy Clinical Research Network
Results: Available at http://public.drcr.net/PDFs/OCTdiurnalvariationprotocol.pdf

Study: MMD-213: Clinical Trial of Intravenous Combretastatin A4 Phosphate in Patients With Subfoveal CNV in Pathologic Myopia
Sponsor: OXiGENE
Results: Available at http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=OXGN&script=418&layout=0&item_id=996424



Retinal Physician, Issue: October 2007