CLINICAL TRIAL UPDATE
| DRY AMD |
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| ► 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: 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 test 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, 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 ► Study: ZVF: The Zeaxanthin and Visual Function Study (ZVF) Sponsor: Chrystantis, Inc.; Kowa Corp.; Image Technologies, Inc. Status: Currently enrolling Purpose: To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to patients with early and moderate AMD Design: Supportive Care, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study Number of Patients: 60 Inclusion Criteria: diagnosis of atrophic AMD by stereo bio-ophthalmoscopy and at least 1 vision-degrading visual-psychophysical abnormality associated with AMD in 1 or both eyes; clear non-lenticular ocular media (cornea, aqueous and vitreous); free of advanced glaucoma and diabetes or any other ocular or systemic disease that could affect central or parafoveal macula visual function Exclusion Criteria: High-risk retinal characteristics for advanced AMD or advanced AMD for which existing medical/surgical options are available; presence of ophthalmologically significant active exudative, AMD pathology by fluorescein angiography but also a single large drusen, >15, multiple intermediate drusen, parafoveal geographic atrophy or loss of vision in 1 eye due to advanced AMD; recent (within 6 months) cataract or retinal surgery; taking photosensitizing drugs such as phenothiazines and chloroquine; having taken lutein or zeaxanthin supplements within the past 6 months. Information: Stuart.Richer1@va.gov ► Study: Copaxone in Age Related Macular Degeneration Sponsor: Kaplan Medical Center Status: Currently enrolling Purpose: To investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone that had been proven as safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet AMD Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Dry AMD in both eyes; age 50 or above. Exclusion Criteria: Known sensitivity to mannitol or copaxone; skin disease or active infection of skin, active fever or active treatment for infection; premenapausal females not using reliable birth control; sensitivity for flourescein or iodine. Information: doctor.landa@gmail.com ► Study: OT-551 Antioxidant Eye Drops to Treat Geographic Atrophy in Age-Related Macular Degeneration Sponsor: National Eye Institute Status: Currently enrolling Purpose: To characterize the effect of 0.45% concentration of OT-551 eye drops given 3 times a day on the progression of geographic atrophy area over a 2-year period Design: Treatment Number of Patients: 50 Inclusion Criteria: Participants must be able to administer the eye drops or have a caretaker administer the eye drops; must have geographic atrophy (GA) present in both eyes compatible with AMD; must have a steady fixation in the study eye in the foveal or parafoveal area and media clear enough for good quality photographs. Exclusion Criteria: Patient <60 years old; evidence of ocular disease other than AMD; psuedovitelliform macular degeneration; vitreoretinal traction maculopathy; history of laser, PDF, or any intravitreal agent treatment Information: (800) 411-1222 |
| WET AMD |
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| ► 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 (intraretinal 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 than 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@barnesretina institute.com ► Study: ASaP: Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration Sponsor: Potentia Pharmaceuticals, Inc. Status: Currently enrolling Purpose: To provide initial safety and tolerability information for a larger phase 2 study of intravitreal POT-4 and for phase 1 studies of POT-4 slow-release formulations for treatment of patients with AMD. Study Design: Prospective, uncontrolled, non-randomized, single-masked, singledose 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 non-proliferative diabetic retinopathy, or proliferative diabetic retinopathy; decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; cataract surgery within 3 months of enrollment; presence of hemorrhage greater than 50% of the CNV lesion; history of treatment for CNV in the study eye, peribulbar corticosteroid injection within 6 months prior to the start of the trial, or oral steroid use at any time during the 30 days prior to randomization; intraocular surgery (including lens replacement surgery) within 6 weeks prior to randomization; medical problems that make consistent follow-up over the treatment period unlikely (eg, stroke, severe MI, endstage malignancy), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections; history of coronary artery disease or cerebral vascular disease; hypersensitivity to fluorescein Information: federico@potentiapharma.com ► Study: A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD Sponsor: Oregon Health and Science University Status: Currently enrolling Purpose: To understand whether genes or certain factors in the environment determine how eyes will respond to Lucentis (ranibizumab) treatment 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: 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 antiangiogenic or intravitreal antiangiogenic agents in study eye; previous radiation therapy to the eye, head, or neck; diagnosis of diabetes Information: (510) 933-7650, info@neovistainc.com ► Study: COBALT: Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD Sponsor: Opko Health, Inc. Status: Currently enrolling Purpose: To compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial 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 within 12 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 reducedfluence 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 1 year; Hgb A1C <6; VA 20/60 to 20/400; lesion size <12 Disc Area; submacular hemorrhage less than 75% of total lesion; submacular fibrosis less than 25% of total lesion Exclusion Criteria: PDT within 3 months; anti-VEGF therapy within 6 weeks; intravitreal or 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 ► Study: A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD Sponsor: Jerini Ophthalmic Status: Currently enrolling Purpose: To determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin 5 1-antagonist is absorbed, broken down, and eliminated from the body when it is given as a single dosage strength by injection into the eye Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study Number of Patients: 36 Inclusion Criteria: Best-corrected visual acuity in the study eye between 20/40 and 20/320, and better or equal to 20/40 in the fellow eye using an ETDRS chart; subfoveal choroidal neovascularization (CNV) due to AMD; total area of the lesion (including blood, neovascularization and scar/atrophy) must be ≥12 DA, of which at least 50% must be active CNV; for patients with occult or non classic CNV; there must be the presence of subretinal hemorrhage (but still comprising no more than 50% of the lesion) and/or documented evidence of three or more lines of vision loss (ETDRS or equivalent) during the previous 12 weeks; clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening; intraocular pressure of 21 mm Hg or less; retinal thickness ≥250 μm by OCT. Exclusion Criteria: Any prior PDT in the study eye; previous therapeutic radiation to the eye; any retinovascular disease or retinal degeneration other than AMD; serous pigment epithelial detachment without the presence of neovascularization; presence of pigment epithelial tears or rips; previous posterior vitrectomy or retinal surgery; any periocular infection in the past 4 weeks Information: (919) 226-1440 ×325 ► Study: Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST) Sponsor: Retina Vitreous Associates, P.C.; Genentech Status: Currently enrolling Purpose: To test the safety, tolerability and effectiveness of a higher dose (1.0 mg) of ranibizumab versus the standard dose (0.5 mg), in adults with agerelated macular degeneration who have never been treated with ranibizumab. Design: Treatment, Randomized, Open Label, Parallel Assignment Number of Patients: 30 Inclusion Criteria: Treatment naive macular degeneration patients with choroidal neovascularization; >50 years old; visual acuity 20/40 to 20/320 Exclusion Criteria: Pregnancy or previous history of thromboembolic event including myocardial infarction or stroke Information: cawh@aol.com ► Study: Sensitivity of the Home Macular Perimeter (HMP) Sponsor: Notal Vision Ltd Status: Currently enrolling Purpose: To estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD Design: Cohort, Prospective Number of Patients: 20 Inclusion Criteria: Subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV; age >50 years; VA with habitual correction >20/200 in study eye; familiar with computer usage Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in the study eye; presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP, or FA; any non-macular-related ocular surgery performed within 3 months prior to study entry in the targeted eye; inability to tolerate intravenous FA; participation in another study with the exclusion of AREDS study Information: osnat@notalvision.com ► Study: A Study to Evaluate the Pharmacodynamics, Safety, and Pharmacokinetics of Pazopanib Drops in Adult Subjects With Neovascular AMD Sponsor: GlaxoSmithKline Status: Currently enrolling Purpose: To evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients Design: Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study Number of Patients: 60 Inclusion Criteria: Age-related macular degeneration patients diagnosed with subfoveal choroidal neovascularization in the study eye, with all of the following characteristics required: central subfield thickness >300 μm on investigator-determined OCT (inclusive of subretinal fluid); active subfoveal leakage as determined by investigator-determined fluorescein angiography; minimally classic or occult with no classic CNV lesion; lesion size no greater than 12 disc areas; CNV >50% of lesion area; <50% of lesion area with blood; = 25% of lesion area with fibrosis; best-corrected ETDRS visual acuity in the study eye between 80 to 24 letters inclusive (approximately 20/25 and 20/320 or 4/5 to 4/63) at screening Exclusion Criteria: Additional eye disease in the study eye that could compromise BCVA (ie, glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, or retinitis pigmentosa); CNV in the study eye due to other causes unrelated to age-related macular degeneration; presence of retinal angiomatous proliferation (RAP) in the study eye, as determined by the investigator (confirmation by indocyanine green angiography is not required); geographic atrophy involving the center of the fovea in the study eye; anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation of the fundus for photographs, fluorescein angiography and OCT; vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD; more than one prior photodynamic therapy (PDT) treatment in the study eye Information: (877) 379-3718 ► Study: Phase 1, Safety, Tolerability, and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration Sponsor: Ophthotech Corp. Status: Currently enrolling Purpose: To evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to AMD. Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study Number of Patients: 18 Inclusion Criteria: Subfoveal CNV due to AMD Exclusion Criteria: Diabetic retinopathy; history or evidence of severe cardiac disease; history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation; clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function; stroke (within 12 months of trial entry); any major surgical procedure within 1 month of trial entry. Previous therapeutic radiation in the region of the study eye; any treatment with an investigational agent in the past 60 days for any condition Information: denise.teuber@ophthotech.com ► Study: CATT: Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial Sponsor: National Eye Institute Status: Currently enrolling Purpose: To evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule. Design: Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 1200 Inclusion Criteria: Active, subfoveal choroidal neovascularization (CNV; subretinal hemorrhage and fibrosis <50% of total lesion area; VA 20/25-20/320; age ≥50 yrs; at least 1 drusen (>63 μm) in either eye or late AMD in fellow eye Exclusion Criteria: Previous treatment for CNV in study eye; other progressive retinal disease likely to compromise VA; contraindications to injections with Lucentis or Avastin Information: dan.martin@emory.edu |
| SCREENING |
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| ► 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 poly morphisms 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 1 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 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 |
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| ► 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 |
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| ► 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: Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema Sponsor: Allergan Status: Enrolling patients Purpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of DME 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), 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 fullscatter 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 involving the center of the fovea with central macular thickness >275 μm in the center subfield, as assessed on OCT and confirmed by the central reading center at screening and by the evaluating physician on Day 0; known duration of DME of ≥2 years; BCVA score in the study eye of 20/40 to 20/320 approximate Snellen equivalent using the ETDRS protocol at an initial testing distance of 4 meters, confirmed by the investigator; decrease in vision determined to be 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: Topical Ocular Mecamylamine in Diabetic Macular Edema (DME) Sponsor: CoMentis/Juvenile Diabetes Foundation Status: Currently enrolling Purpose: To evaluate the safety and tolerability of topical ocular mecamylamine given twice a day in patients with DME Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment Inclusion Criteria: Macular edema due to diabetic retinopathy Exclusion Criteria: Vision loss from other ocular disease; intraocular surgery within 3 months; intraocular anti-VEGF or steroids within 3 months; HbA1c >12 Information: (410) 502-0768 ► Study: A Study of the Safety and Efficacy of a New Treatment in Combination With Laser for Macular Edema Resulting From Diabetic Macular Edema Sponsor: Allergan Status: Enrolling patients Purpose: To evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs laser treatment alone in patients with DME Design: Treatment, Randomized, Single-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 250 Inclusion Criteria: Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse) and visual acuity in other eye no worse than 20/200 Exclusion Criteria: History of glaucoma or current high eye pressure requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids; use of warfarin/heparin Information: clinicaltrials@allergan.com ► Study: A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin for Treatment of Patients With DME Sponsor: ThromboGenics Status: Currently enrolling Purpose: To compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME Design: Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study Number of Patients: 60 Inclusion Criteria:>18 years old with DME Exclusion Criteria: PVD present at baseline; vitreous hemorrhage; certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR); patients who have had a vitrectomy in the study eye at any time Information: (212) 201-0920 ×277 |
| RETINAL VEIN OCCLUSION |
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| ► 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 Website at http://spitfire.emmes.com/study/score Number of Patients: 1260; 630 with CRVO and 630 with BRVO Sites: 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 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 (DME, proliferative diabetic retinopathy, or high-risk nonproliferative diabetic retinopathy); pregnancy Information: (713) 524-3434 ► Study: CRUISE: A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion Sponsor: Genentech Status: Currently enrolling Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to CRVO 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, hemiretinal vein occlusion or branch retinal vein occlusion Exclusion Criteria: Active gout or high levels of uric acid Information: gaynonM@pamf.org |
| UVEITIS |
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| ► 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; BCVA of 20/200 in at least 1 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 antiglaucoma 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 ► 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 with prednisolone 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 anterior uveitis in at least 1 eye Exclusion Criteria: Presence of intermediate uveitis, posterior uveitis, or panuveitis; corneal abrasion or ulceration; any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease; allergy to similar drugs, such as other corticosteroids Contact: (813) 496-7325 ×300 or clinical.trials@siriontherapeutics.com ► Study: Phase 2 Study of MM-093 to Treat Patients With Uveitis Sponsor: Merrimack Pharmaceuticals Status: Currently enrolling Purpose: To evaluate the tolerability, pharmacokinetics, pharmacodynamics, and biologic activity of MM-093 in patients with moderate to severe uveitis Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 20 Inclusion Criteria: Documented diagnosis of sarcoid or birdshot uveitis for at least 6 months as defined by each of the following: inflammatory cells in the anterior chamber and/or vitreous body ≥2+; and loss of visual function as reflected by a prolongation of 30 Hz scotopic implicit time on ERG testing and/or loss of vision to the 20/40 level or lower on visual acuity testing for patients with birdshot retinochoroidopathy Exclusion Criteria: Significant concurrent medical disease or prior medications or treatments up to 2 months before study begins Information: (617) 441-1000 ► Study: Immune Indicators of Uveitis Sponsor: National Eye Institute Status: Enrolling patients Purpose To identify markers of immune activity in uveitis patients that correlate with the state of disease activity. Design: Observational Number of Patients: 100 Inclusion Criteria: Patients with bilateral sight threatening uveitis requiring systemic immunotherapy who are 18 years and older are eligible. Disease can be active or quiescent, but subjects must be on a minimum prescribed therapy upon enrollment of a dose averaging at least 20 mg/day (or greater than or equal to 0.25 mg/kg/day) of systemic prednisone or a more intensive immunosuppression regimen. More intensive regimens may include from 1 to 3 antiinflammatory treatments for uveitis that include any 1 of the following (or related) compounds: corticosteroids (including systemic or periorbital administration), topical corticosteroids (when used in combination with other agents), cyclophosphamide, cyclosporine, azathioprine, chlorambucil, tacrolimus, leflunomide, mycophenolate mofetil, or methotrexate; patients who have noninfectious intermediate, posterior, or panuveitis of at least 3 months duration. Included conditions may include but are not limited to intermediate uveitis of the pars planitis subtype, sarcoidosis, the Vogt-Koyanagi-Harada (VKH) syndrome, birdshot retinochoroidopathy, retinal vasculitis and sympathetic ophthalmia. Exclusion Criteria: Pregnancy; having another disease or condition affecting vision that will interfere with obtaining study data Information: prpl@mail.cc.nih.gov ► Study: Quality of Life and Visual Function in Uveitis Patients Sponsor: New York Eye & Ear Infirmary Status: Currently enrolling Purpose: To measure the quality of visual function and quality of daily living in patients with anterior, posterior, and panuveitis. Design: Screening, Cross-Sectional, Defined Population, Prospective Study Number of Patients: 50 Inclusion Criteria: Age >18 years old; diagnosis of uveitis Information: (212) 979-4251 |
| OTHER |
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| ► 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: Open-Label, Pilot Study of TG100801 in Patients With Choroidal Neovascularization Due to AMD Sponsor: TargeGen Information: shorr@targegen.com ► Study: ADVANCE: Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration Sponsor: Novartis Information: (862) 778-8300 ► Study: A Study of an Encapsulated Cell Technology (ECT) Implant for Patients With Atrophic Macular Degeneration Sponsor: Neurotech Pharmaceuticals Information: clinicalcontact@neurotechusa.com ► Study: Safety and Tolerability of MS-R001 in Patients With DME Secondary to Diabetic Retinopathy Sponsor: MacuSight Information: (602) 222-2221 or (817) 749-0180 ► Study: Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema Sponsor: Alimera Sciences Information: ghafiz@jhmi.edu ► Study: FAME (Fluocinolone Acetonide in Macular Edema) Sponsor: Alimera Sciences & Controlled Delivery Systems Information: (877) 285-4559 ► Study: Reduction in the Occurrence of Center-threatening DME Sponsor: Eli Lilly and Company Information: (877) 285-4559 ► Study: Lucentis for Central Retinal Vein Occlusion (CRVO) Sponsor: California Retina Consultants/Genentech 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 Information: clinicaltrials@allgeran.com |
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