A Study of the Safety and Tolerability of ASP7317 in Adults Who Are Losing Their Clear, Sharp Central...
Age-Related Macular DegenerationThis study is for adults 50 years or older who are losing their clear, sharp central vision. Central vision is needed to be able to read and drive a car. They have been diagnosed with dry age-related macular degeneration (called dry AMD). The macula is the center part of the back of the eye that allows you to see fine detail. In an advanced stage of this disease, areas of the macula die (atrophy), resulting in vision loss. This is called geographic atrophy. This study is looking at a new treatment called ASP7317. It is for slowing or reversing atrophy in dry AMD. ASP7317 is a specially created type of cells derived from human stem cells. ASP7317 cells are injected into the macula of the eye while the person is under anesthesia (local or general). An immunosuppressive medicine (tacrolimus) is also taken around the time of injection of the cells to prevent the body from rejecting them. This study looks at how safe ASP7317 is at 3 different dose levels. Researchers want to learn if the different dose levels of ASP7317 work without causing unwanted medical problems. Each of the 3 doses will be given to 2 groups of people. The first group will be those who have severe vision loss. The second group will be those who have moderate vision loss. The doses are low, medium and high numbers of cells. Tacrolimus will be taken by mouth for 34 days, starting around the time of the injection of ASP7317. In addition, medicines to prevent infection will be taken by mouth for up to 4 weeks starting around the time ASP7317 cells are injected. Each week for the first 4 weeks after the ASP7317 cells have been injected, people taking part in the study will visit the clinic so the researchers can make assessments. Then they will visit again, at weeks 6, 8, 12, 16, 26, and 52 (last week of the study). A substudy will be available at some clinics. These clinics will use a special camera that will allow researchers to look at images of the macular atrophy over time.
Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy...
Age-Related Macular DegenerationThis is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.
A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment...
Geographic AtrophyMacular DegenerationThe purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
Geographic AtrophyMacular DegenerationPatients who completed Study ISEE2008 (GATHER2) and consent to participate will be administered monthly avacincaptad pegol 2 mg.
Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)
Age-Related Macular DegenerationDry Age-related Macular Degeneration1 moreEvaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).
Multicenter Clinical Study of the SING-IMT in Patients With Late-stage AMD
Age-Related Macular DegenerationGeographic AtrophyThe objective of this study is to determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD).
Oral Postbiotics in Patients With Macular Atrophy
Geographic AtrophyAge-Related Macular DegenerationA pilot study to evaluate the safety and efficacy of oral therapy with Postbiotics in patients with geographic atrophy secondary to age-related macular degeneration, myopia, or angioid streaks.
An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects...
Geographic Atrophy Secondary to Age-related Macular DegenerationThis is a phase 3, open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan (APL-2) in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who participated in Study APL2-103 (NCT03777332) or completed the treatment at Month 24 of either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600).
ONL1204 Ophthalmic Solution in Patients With Geographic Atrophy Associated With Age-related Macular...
Geographic AtrophyThe purpose of this study is to evaluate the safety and tolerability of intravitreal injection of ONL1204 Ophthalmic Solution in patients with geographic atrophy associated with AMD. GA associated with AMD is one of the world's leading causes of visual disability. It is a progressive disease with no approved therapy to slow or arrest the process of continual photoreceptor and retinal epithelial (RPE) cell loss. A safe and effective therapy for GA will have vast societal benefits. ONL1204 is being developed for this purpose. ONL1204 is a first-in-class inhibitor of fragment apoptosis stimulator receptor-mediated cell death in development for to reduce rates of vision in patients with GA associated with AMD. ONL1204 has demonstrated protection of multiple retinal cell types in several preclinical models of acute ocular injury and the protection of RPE in AMD models. ONL1204 Ophthalmic Solution is currently in a Phase 1 clinical study in patients with macula-off retinal detachment to evaluate safety and tolerability of a single-dose of ONL1204 Ophthalmic Solution. The study is ongoing and uses the same doses and route of administration as this Phase 1b study in patients with GA.
Phase 3 Study of ALK-001 in Geographic Atrophy
Geographic AtrophyAge Related Macular Degeneration3 moreThis is a double-masked, multicenter, randomized, placebo-controlled clinical trial, evaluating the efficacy and safety of ALK-001 in participants with Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD). Up to 200 participants will receive ALK-001 while up to 100 participants will receive a placebo.