A Study to Test How Well Different Doses of BI 771716 Are Tolerated by People With an Advanced Form...
Geographic AtrophyThis study is open to adults with geographic atrophy, an advanced form of age-related macular degeneration. People can join the study if they are at least 50 years old. The purpose of this study is to find out how well different doses of a medicine called BI 771716 are tolerated. This study has 2 parts. Part 1 of the study takes about 3 months. In this part, participants receive 1 injection of BI 771716 directly into one of the eyes affected by geographic atrophy. Part 2 of the study takes about 4 months. In this part, participants receive 2 injections of BI 771716 directly into the eye. There are 4 weeks between the first and the second injection. In this study, BI 771716 is given to humans for the first time. The doctors compare how well participants tolerate the different doses of BI 771716. The doctors also regularly check the general health of the participants.
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic...
Geographic AtrophyThis Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (LBS-008) in subjects diagnosed with GA.
Subthreshold Laser Treatment in Intermediate Age-related Macular Degeneration With Nascent Geographic...
Age-Related Macular DegenerationThis study is a prospective, single centre, randomized, sham-controlled, double-masked, clinical trial which aims to investigate the effect of subthreshold nanosecond laser on disease progression in eyes with intermediate age-related macular degeneration (AMD) and nascent geographic atrophy by functional and anatomical outcomes. The study population will be individuals with high-risk intermediate age-related macular degeneration who meet all eligibility criteria. 60 subjects total (30 randomized to receive subthreshold nanosecond laser (SNL) treatment and 30 to receive sham treatment as per the 1:1 randomization). The study has a 12-month study period with four scheduled visits: screening, randomisation (first treatment), 6-month follow up visit (with second treatment where eligible), 12-month follow-up. The primary outcome is the proportion of laser-treated study eyes that develop late AMD compared to sham-treated study eyes over 12 months. The key secondary outcome is the change in retinal function of laser-treated study eyes compared to sham-treated study eyes over 12 months. Safety will be the proportion of laser-treated eyes that lose 10+ letters of vision (measured on a standard vision chart) compared to sham-treated eyes over 12 months.
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for...
Age-Related Macular DegenerationBackground: Age-related macular degeneration is a common eye disease in people over 50. The "dry" form of the disease can worsen into geographic atrophy, causing blind spots. Researchers want to learn if replacing older eye cells with younger ones can help treat this disease. Objective: To test the safety of putting cells inside the eye as a possible future treatment for dry age-related macular degeneration. Eligibility: People ages 55 and older who have geographic atrophy with loss of vision. People who have had "wet" macular degeneration in either eye are NOT eligible. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Eye exam Eye photos Fluorescein angiography. An intravenous (IV) line is placed in an arm vein. A dye is injected. A camera takes pictures of the dye as it flows through the eyes' blood vessels. Electroretinography. An electrode is taped to participants' forehead. They sit in the dark. After 30 minutes, numbing eye drops and contact lenses are placed in their eyes. They watch flashing lights. Tuberculosis test Chest X-ray Electrocardiography. Sticky pads are placed on participants' chest to record the heart's electrical activity. Participants will have at least 14 study visits over 5 and a half years. They will repeat screening tests. Participants will have retinal pigment epithelium (RPE) transplantation surgery in one eye. For this, cells from participants' blood are turned into RPE cells. These cells are placed in their eye through a cut in their retina. They will get dilating eye drops, an IV line, and anesthesia that may make them sleep. A gas bubble will be put in their eye to help it heal. Participants will be contacted yearly for up to 15 years.
Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy
Age-related Macular Degeneration (AMD)The primary objectives of the study are to assess the safety, tolerability and evidence of activity of 12 months oral treatment with TEFIDERA® in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration...
Macular DegenerationSenile4 moreProspective, randomized, controlled, longitudinal, interventional multicentric study involving patients with reticular pseudodrusen secondary to AMD. The objective of this study is to establish the effectiveness of subthreshold laser treatment in increase/prevent the decrease of the retinal sensibility in patients with reticular pseudodrusen, and to reduce the progression of RPD to atrophy. Approximately 50 naïve patients with reticular pseudodrusen who underwent subthreshold laser treatment in perifoveal area. These patients should be randomized in the 2 study arms of the study. Patients will be evaluated at Screening/Baseline and then revaluated and retreated at month 3, 6 and 9. At month 12, all patients will be evaluated with a full ocular examination, visual acuity measurement (VA), optical coherence tomography (OCT) with autofluorescence, OCT-angiography and microperimetry. The rationale of the study is to prevent the evolution of reticular pseudodrusen to atrophic degeneration.
A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen...
Geographic AtrophyThis study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). All endpoints are assessed for the study eye unless otherwise indicated.
Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-related Macular DegenerationGeographic AtrophyThis safety study comprises a dose escalation study of VOY-101, followed by a cohort of subjects randomized to the maximum tolerated dose arm, a lower dose arm, and control arm.
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Geographic AtrophyThis is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (AMD). This is a multicenter study, which will be conducted in two phases and will enroll up to a total of 63 subjects.
A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration...
Geographic Atrophy of the MaculaMacular DegenerationInvestigate the Safety, Pharmacokinetics, and Treatment effects of Single and Multi-dose of Intravitreal AVD-104 in participants with geographic atrophy secondary to age-related macular degeneration.