Retinal Physician

JAN-FEB 2017

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58 R E T I N A L P H Y S I C I A N . C O M | N O V E M B E R / D E C E M B E R 2 0 1 6 CLINICAL TRIAL UPDATE Study: A Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura® (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration Sponsor: Ophthotech Purpose: To evaluate the safety and efficacy of intravitreous administration of Zimura when administered in subjects with geographic atrophy (GA) secondary to dry age-related macular degeneration Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind Number of Patients: 300 Inclusion Criteria: Diagnosis of Non-foveal GA secondary to dry AMD Exclusion Criteria: Retinal atrophy involving the fovea; evidence of CNV; any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals; any intraocular surgery or thermal laser within 3 months of trial entry; any prior thermal laser in the macular region, regardless of indication; any ocular or periocular infection in the 12 weeks prior to entry; previous therapeutic radiation in the region of the study eye; any sign of diabetic retinopathy in either eye Information: Desiree.Beutelspacher@ Ophthotech.com Study: BioCurrent Electrical Stimulation for the Treatment of Dry ARMD Sponsor: DuBois Vision Clinic Purpose: To evaluate the treatment of Dry Macular Degeneration and the resulting change in vision with a very, very low current that is similar to what occurs in the body naturally Design: Randomized, Safety/Efficacy, Crossover Assignment, Double-blind Number of Patients: 616 Inclusion Criteria: Best-corrected visual acuity can be no better than 20/40 and no worse than 20/200 for each enrolled eye; confirmed diagnosis of Dry MD; vision loss attributable to Dry MD Exclusion Criteria: Any retinal pathology other than Dry MD; evidence or history of wet MD; previous intravitreal injection; seizure disorders; dense cataract; eyelid pathology at the treatment sites surgery, submacular surgery, or other surgical intervention for AMD; previous subfoveal focal laser photocoagulation; laser photocoagulation in the study eye; previous intravitreal drug administration; GA in either eye due to causes other than AMD Information: global.rochegenentechtrials@ roche.com Study: Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With AMD Sponsor: National Eye Institute Purpose: To see if minocycline is safe for people with GA and if it helps preserve their vision Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind Number of Patients: 66 Inclusion Criteria: Participant must have evidence of early or intermediate AMD as defined by characteristic presence of drusen and/or pigmentary changes; participant must be able to swallow capsules Exclusion Criteria: Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve (eg, ethambutol, chloroquine, or hydroxychloroquine); participant has a condition that would preclude participation in the study Information: meg.gordon@nih.gov Study: Evaluation of Lipoic Acid as a Treatment for Geographic Atrophy Sponsor: University of Pennsylvania Purpose: To determine if there are safety/ tolerability concerns seen when higher doses of alpha lipoic acid are taken by subjects 65 years of age or older Design: Safety, Single Group, Open Label Number of Patients: 15 Exclusion Criteria: Blood pressure greater than 190/100 at the baseline visit; pulse greater than 100 at the baseline visit; acute and ongoing systemic infection; history of dementia; participant has a condition that, in the opinion of the investigator, gives them an unstable medical status; participant has geographic atrophy and the investigator believes the participant is a candidate for enrollment into the planned Phase 2 trial for geographic atrophy Information: benjamin.kim@uphs.upenn.edu DRY AMD Study: TOGA: Clinical Study to Evaluate Treatment With ORACEA for Geographic Atrophy Sponsor: Paul Yates, MD, PhD/MEDARVA Purpose: To evaluate the efficacy and safety of ORACEA in the treatment of geographic atrophy due to dry age-related macular degeneration Design: Randomized, Parallel Assignment, Double-blind Number of Patients: 286 Inclusion Criteria: Best-corrected visual acuity of 20/20 - 20/400 in the study eye; best-corrected visual acuity of hand motion or better in the non-study eye; clinical diagnosis of geographic atrophy secondary to non- exudative age-related macular degeneration in at least one eye (study eye); geographic atrophy lesions of ≥ 0.5 and ≤ 7.0 MPS disc areas Exclusion Criteria: History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the study eye; history of or active presence of choroidal neovascularization secondary to exudative AMD in the non-study eye requiring any treatment within 12 months prior to Day 0 Information: klh7v@virginia.edu Study: A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy Sponsor: Genentech Purpose: To investigate the exposure- response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in patients with geographic atrophy (GA) secondary to AMD Design: Randomized, Safety/Efficacy, Parallel Assignment, Single-blind Number of Patients: 100 Inclusion Criteria: Patients aged 60-89 years with well-demarcated area of GA secondary to AMD in the absence of choroidal neovascularization Exclusion Criteria: History of vitrectomy 58 R E T I N A L P H Y S I C I A N | J A N U A R Y / F E B R U A R Y 2 0 1 7

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