Article Date: 6/1/2007

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 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: OT-551

Sponsor: Othera

Status: Enrolling patients

Purpose: To investigate whether the topically applied antioxidant OT-551 can help slow progression of atrophic "dry" AMD

Study Design: Randomized, double-masked, dose-ranging, multi-center, efficacy and safety study

Number of Patients: 200

Inclusion Criteria: ≥55 years of age; clinical diagnosis of geographic atrophy in one or both eyes; area of the geographic atrophy does not exceed 7 MPS disc areas; best corrected visual acuity score of 20/63 (Snellen equivalent) or better; geographic atrophy is not secondary to conditions other than AMD; no choroidal neovascularization in either eye; no confounding ocular conditions or recent or planned surgery in the study eye.

Information: Al Reaves, MD, reaves@othera.com

► 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; visual acuity of less than or equal to 20/70 and greater than or equal to 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: Safety Study in Retinal Transplantation for Dry AMD

Sponsors: Ocular Transplantation, National Neurovision Research Institute

Status: Enrolling patients

Purpose: To show that retinal transplantation can help to prevent blindness and to 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: Decreased central visual acuity of 20/200 or worse in 1 eye by ETDRS vision testing for a duration of at least 1 year in the operated eye; vision in the nonoperated eye must be better than the operated eye; vision in the operated eye cannot be better than 20/200; >55 years of age; patient has undergone microperimetry and Goldmann visual field testing

Exclusion Criteria: Medical problems that are contraindicatory for short-term anesthesia; pregnancy; features of any condition other than AMD in the study eye (such as pathologic myopia or presumed ocular histoplasmosis) associated with choroidal neovascularization; history of choroidal neovascularization in the study eye; prior photodynamic therapy or Macugen therapy for choroidal neovascularization; history of uveitis, Coat's disease, diabetic retinopathy, glaucoma, or a cataract that prevents visualization of the posterior pole

Information: (502) 636-2823

► 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) 957-3449

► 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 choroidal neovascularization (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 age-related macular degeneration with the presence of geographic atrophy; visual acuity 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

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)Eyetech/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: Safety and Efficacy of Repeated Intravitreal Administration of VEGF Trap in Patients with Wet AMD

Sponsor: Regeneron Pharmaceuticals

Status: Enrolling patients

Purpose: To assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal CNV due to AMD

Design: Phase 2, randomized, double-blind, dose comparison, parallel assignment, safety/efficacy

Number of Patients: 150

Inclusion Criteria: Age >50 years; subfoveal CNV secondary to AMD; central retinal (including lesion) thickness ≥300 μm as measured by OCT; ETDRS BCVA of 73-34 letters

Exclusion Criteria: History of any vitreous hemorrhage within 4 weeks prior to day 1; aphakia; significant subfoveal atrophy or scarring; prior treatment with the following in the study eye: subfoveal thermal laser therapy, submacular surgery, or other surgical intervention for the treatment of AMD; extrafoveal laser coagulation treatment within 12 weeks prior to day 1; PDT within 12 weeks prior to visit 2 (day 1); pegaptanib sodium within 8 weeks of visit 2 (day 1); juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to visit 2 (day 1); intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to visit 2 (day 1) unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy; prior systemic or intravitreal treatment with VEGF Trap, ranibizumab, or bevacizumab

Information: Regeneron, VEGF.Trap@regeneron.com

► 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 age related macular degeneration (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, 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 choroidal neovascularization (CNV)" due to wet AMD

Number of Patients: 10

Inclusion Criteria: Age >50 years old; must have media clear enough to permit fundus photography, fluorescein angiography, and optical coherence tomography

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 fluorescein angiography 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 choroidal neovascularization associated with age-related macular degeneration

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 visual acuity (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 choroidal neovascularization secondary to age-related macular degeneration

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 choroidal neovascularization (CNV) due to age-related macular degeneration (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

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 um 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 six 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 DA

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 greatest linear dimension (GLD) ≥5400 μm (approximately ≥9 disc areas [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 fluorescein angiographic (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, 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 three 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@potentia pharma.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 photodynamic therapy (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

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 optical coherence tomography (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: Metabolic Mapping to Measure Retinal Metabolism

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To test whether a new non-invasive technique can quickly and precisely measure retinal metabolism (the amount of energy retinal cells use)

Design: Diagnostic, Nonrandomized, Open-label, Uncontrolled, Single-group Assignment, Efficacy Study

Number of Patients: 30

Inclusion Criteria: Presence of a natural lens in the study eye; age 60 years or older

Exclusion Criteria: Ocular disease (other than AMD) that confounds assessment of the retina including diabetic retinopathy, central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration

Information: (800) 411-1222

► Study: AMD DOC Study (Age-Related Macular Degeneration: Detection of Onset of New Choroidal Neovascularization)

Sponsor: Johns Hopkins University

Status: Enrolling patients

Purpose: To compare the ability of the Preferential Hyperacuity Perimeter (PHP) to that of the Amsler grid in detecting neovascular AMD in eyes at high risk for CNV development

Design: Screening, Longitudinal, Defined Population, Prospective Study

Number of patients: 180

Inclusion Criteria: Age ≥50; best corrected visual acuity letter score = 65 or greater (approximate Snellen equivalent of 20/50 or better in the candidate study eye); neovascular AMD in the fellow eye and no CNV in the candidate study eye (absence of CNV confirmed by FA which will be graded in a masked fashion by the AMD DOC Study Reading Center); candidate study eye must have evidence of at least 1 large druse (≥125 μm) and focal hyperpigmentation within 3600 μm of the fovea and visible on color fundus photography; must have media clear enough in the candidate study eye to permit fundus photography, fluorescein angiography, and optical coherence tomography and absence of any fluorescein allergies.

Exclusion Criteria: Known allergy to fluorescein angiography or allergic reaction during screening; advanced AMD with CNV in both eyes confirmed on FA graded by the AMD DOC Study Reading Center; foveal geographic atrophy in the study eye; significant media opacity that precludes reasonable quality retinal imaging including color fundus photographs, fluorescein angiography, or OCT in the candidate study eye to assess the presence of CNV; evidence of macular disease (eg, pattern dystrophy, diabetic macular edema, vitreomacular traction) other than AMD in the study eye; previous surgical or laser treatment to the macula of the study eye; diabetic retinopathy

Information: (410) 955-3648

► Study: Novel Diagnostics With Optical Coherence Tomography: Retinal Imaging

Sponsor: University of Pittsburgh

Status: Currently enrolling

Purpose: To evaluate optical coherence tomography (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: Evaluation of Vitrectomy for DME

Sponsor: Diabetic Retinopathy Clinical Research Network

Number of sites: 29

Number of patients: Approximately 400

Status: Enrolling patients

Purpose: To provide information on the following outcomes in eyes with DME that undergo vitrectomy: visual acuity, retinal thickening, resolution of traction (if present), surgical complications; to identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial; to obtain data that can be used to plan a randomized trial

Design: The study is designed as a prospective cohort study. A cohort study provides the opportunity to collect data prospectively using a standardized protocol to assess the potential benefits and risks of vitrectomy. The results can be used to determine whether proceeding with a randomized trial has merit and what the design of the trial should be. If a randomized trial is to be conducted, the results plus the cohort study experience can be used to help design the RCT protocol

Inclusion/Exclusion Criteria: Age ≥18 years old, study eye with vitrectomy being performed as treatment of DME, study eye with best-corrected visual acuity 20/800 or better (E-ETDRS visual acuity score ≥3 letters)

Information: http://public.drcr.net/studies/ProtocolD_vitrectomy/ProtDInfo.html

► 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: Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

Sponsor: Rocky Mountain Retina Consultants/Genentech

Purpose: To evaluate the clinical efficacy of intravitreal injections of ranibizumab (Lucentis) in the treatment of DME 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 mm of the center of the fovea; hard exudates within 500 mm 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; visual acuity <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 non-central subfield; media clarity and pupillary dilatation, 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: IOP exceeds 25 mm Hg; pregnancy or premenopausal women not using birth control; 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

Information: (801) 264-4444

► 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; visual acuity of 20/40 to 20/200 in study 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: Intravitreal vs Sub-Tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide (TAC-PF) at 2 dosage levels (4 mg and 8 mg) compared to anterior sub-tenon injections of TAC-PF at 20 mg

Design: Masked, randomized, interventional phase 1 study

Number of Patients: 120

Inclusion Criteria: Retinal thickening due to macular edema in the study eye; retinal thickness greater than or equal to 250 μm in the central subfield on OCT; BCVA equal to or worse than 20/40 in the study eye; sufficiently clear ocular media to permit good quality retinal photographs and angiography to allow assessment of macular area according to standard clinical practice

Exclusion Criteria: IOP greater than 25 mm Hg or history suggesting glaucoma or glaucomatous visual field defects as documented by Goldmann or Humphrey perimetry taken within 6 months to qualification; allergy to fluorescein dyes; blood pressure greater than 180/110; use of medications known to be toxic to the lens, retina, or optic nerve; previous experimental therapies for the present disease in the past 3 months; history of or current acute ocular or periocular infection; major intraocular surgical procedure within 1 month of enrollment; use of systemic steroids in excess of an average 20 mg daily dose for the past 3 months; history of untoward complications from corticosteroid therapy, including elevated intraocular pressure in response to topical or periocular corticosteroids

Information: (800) 411-1222

► 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 visual acuity in at least one 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: READ-2 (Ranibizumab for Edema of the mAcula in Diabetes)

Sponsor: Johns Hopkins/Juvenile Diabetes Research Foundation/ Genentech

Status: Enrolling patients

Purpose: To compare ranibizumab to laser therapy in the treatment of DME

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Number of Patients: 125

Inclusion Criteria: Diagnosis of diabetes mellitus; retinal thickening secondary to diabetes mellitus (diabetic macular edema) involving the center of the fovea; diagnosis must be confirmed by OCT images; foveal thickness of greater than 250, as assessed by OCT; BCVA score in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 m)

Exclusion Criteria: Panretinal photocoagulation 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, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry; proliferative diabetic retinopathy in the study eye, with the exceptions of inactive, fibrotic proliferative diabetic retinopathy that has regressed following pan-retinal laser photocoagulation or tufts of NVE less than 1 disc area with no vitreous hemorrhage; vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT; structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular ischemia, or organized hard exudate plaque; ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause; concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the first 6-month study period; eyes that are likely to need cataract surgery and intraocular lens implantation within the first 6 months of the study; cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 2 months of study entry; or any other intraocular surgery within 3 months preceding Day 0; history of vitreoretinal surgery in the study eye within 3 months of study entry; uncontrolled glaucoma or diabetes mellitus; premenopausal women not using adequate contraception or pregnant women; history of gastrointestinal bleeding within 2 months of study enrollment, of major gastrointestinal, cardiothoracic, gynecological, genitourinary, or orthopedic surgeries within 2 months of study enrollment, or of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment; anyone on renal dialysis

Information: (410) 502-1713

► Study: The Course of Response to Focal Photocoagulation for DME

Sponsor: National Eye Institute

Status: Currently enrolling

Purpose: To determine the course of changes in OCT measured macular thickness and visual acuity following a single session of focal photocoagulation for center-involved DME

Design: Longitudinal, Defined Population, Prospective Study

Number of Patients: 110

Inclusion Criteria: Age ≥18 years; diagnosis of diabetes mellitus (type 1 or type 2; best-corrected E-ETDRS visual acuity letter score ≥24 (i.e., 20/320 or better) within 8 days of enrollment; definite retinal thickening due to diabetic macular edema involving the center of the macula

Exclusion Criteria: Significant renal disease; blood pressure >180/110 (systolic above 180 OR diastolic above 110); edema caused by other than DME; VA loss that would not improve with treatment of macular edema; substantial cataract

Information: (866) 372-7601

► 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 x218

► 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; diabetic macular edema involving the center of the macula (OCT central subfield thickness >250 μm) responsible for visual acuity 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 visual acuity impairment that can occur following PRP and increase the chances of at least short-term visual acuity 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; diabetic macular edema involving the center of the macula (OCT central subfield thickness >250 μm) and reducing visual acuity to 20/32 or worse

Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolJ_lrtpdr/ProtJInfo.html

► Study: The Course of Response to Focal Photocoagulation for Diabetic Macular Edema

Sponsor: Diabetic Retinopathy Clinical Research Network

Status: Currently enrolling

Purpose: To determine the course of changes in OCT measured macular thickness and visual acuity following a single session of focal photocoagulation for center-involved DME

Study Design: Randomized, Multicenter, Single-group Intervention Study

Number of Patients: 110

Inclusion Criteria: Age >18 years; type 1 or type 2 diabetes; diabetic macular edema involving the center of the macula (OCT central subfield thickness >250 μm)

Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolK_laserresponse/ProtKInfo.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 optical coherence tomography (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 diabetic macular edema; ocular condition is present such that, in the opinion of the investigator, preventing visual acuity loss would not improve from resolution of macular edema; substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity 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

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 central retinal vein occlusion

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 of 1-2e 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 (diabetic macular edema, proliferative diabetic retinopathy, or high-risk non-proliferative diabetic retinopathy); pregnancy

Information: (713) 524-3434

► Study: Lucentis for Macular Edema Secondary to Vein Occlusions

Sponsor: Johns Hopkins/Genentech

Status: Enrolling patients

Purpose: To assess the bioactivity of 3 intravitreous injections 0.5 mg or 0.3 mg of ranibizumab in patients with macular edema due to central and branch retinal vein occlusions and correlate activity with peak and trough aqueous levels

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Number of Patients: 40

Inclusion Criteria: Diagnosis of macular edema due to central or branch retinal vein occlusion; BCVA in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters)

Exclusion Criteria: Scatter laser photocoagulation 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 (e.g., triamcinolone) within 3 months of study entry; previous participation in a study and receipt of antiangiogenic drugs (pegaptanib sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 3 months of study entry; vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT; ocular inflammation (including 1+ or above in the amount of cells) 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 likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular ischemia, or organized hard exudate plaque; ocular disorders in the study eye that may confound interpretation of study results, including diabetic retinopathy, retinal detachment, macular hole, or choroidal neovascularization of any cause (eg, AMD, ocular histoplasmosis, or pathologic myopia); concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period; ontraocular surgery in the study eye within 3 months of study entry; uncontrolled glaucoma; infectious blepharitis, keratitis, scleritis, or conjunctivitis (in either eye) or current treatment for serious systemic infection; blood pressure exceeding 160/95 (sitting) during the screening period; renal failure requiring dialysis or renal transplant; premenopausal women not using adequate contraception; previous participation in other studies of investigational drugs (excluding vitamins and minerals) within 3 months

Information: (410) 955-5106

► 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, central retinal vein occlusion

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 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; 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 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 visual acuity 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 x26

► 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 visual acuity 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

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 least one 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 Immuno-suppressive 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

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, age-related macular degeneration, current eye infection or recent eye surgery, participating in other eye studies

Information: (617) 573-1021

COMPLETED ENROLLMENT

► Study: Combination Bevacizumab and Verteporfin in Neovascular AMD

Sponsor: Retinal Consultants Medical Group

Information: http://www.clinicaltrials.gov/ct/show/NCT00426998?order=1

► Study: Evaluation and Treatment of Patients With Inherited Eye Disease

Sponsor: National Eye Institute

Information: http://www.clinicaltrials.gov/ct/show/NCT00011817?order=1

► Study: A Study Of The Safety And Efficacy Of AG-013,958 In Subjects With Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration

Sponsor: Pfizer

Information: http://www.clinicaltrials.gov/ct/show/NCT00090532?order=1

► Study: An Observational Study of the Development of DME Following Scatter Laser Photocoagulation

Sponsor: Diabetic Retinopathy Clinical Research Network

Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolF_prp/ProtFInfo.html

► Study: Subclinical DME Study

Sponsor: Diabetic Retinopathy Clinical Research Network

Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolF_prp/ProtFInfo.html

COMPLETED TRIALS
► Study: Comparison of Modified Early Treatment Diabetic Retinopathy Study and Mild Macular Grid Laser Photocoagulation Strategies for DME
Sponsor: Diabetic Retinopathy Clinical Research Network
Results: Available at http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17420366&query_hl=2&itool=pubmed_DocSum
► Study: Diurnal Variation in Retinal Thickening Measurement by OCT in Center-involved DME
Sponsor: Diabetic Retinopathy Clinical Research Network
Results: Available at http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17159029&query_hl=4&itool=pubmed_docsum
► 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: June 2007