Tarnowskie Gory

Researchers are evaluating the experimental drugs pozelimab and cemdisiran for treating Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The study aims to compare the progression rate of GA in patients receiving cemdisiran alone, the combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring side effects, drug levels in the blood over time, and the bodys antibody response to these drugs. Participants will receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized and double-masked with three groups receiving different treatments. Treatment and monitoring will continue through specified time points up to 104 weeks, with follow-up on safety and antibody responses extending even further. During the study, participants will attend regular clinic visits for eye exams, imaging using Fundus Autofluorescence to measure GA lesion growth, vision tests including visual acuity and contrast sensitivity, and blood tests to assess drug levels and antibody formation. Researchers will track treatment-emergent adverse events and evaluate changes in vision and GA progression over time. Participation lasts until the study completion date in April 2033, with primary outcomes assessed at 52 weeks and further evaluations up to 296 weeks.

Researchers are evaluating the effects of a medicine called BI 1815368 in adults aged 18 and older who have a specific eye condition known as centre-involved diabetic macular edema CI-DME. This condition affects vision, and the study aims to find out if BI 1815368 can improve sight and to determine the best dose. The trial is a phase 2, randomized, double-masked, placebo-controlled study designed to assess efficacy, safety, and tolerability. The study has two parts. In the first part, participants are randomly assigned to one of two groups one receiving BI 1815368 tablets and the other receiving placebo tablets that look identical but contain no medicine. In the second part, participants are randomly assigned to one of four groups three groups receive different daily doses of BI 1815368, and one group receives placebo. All participants take the tablets twice daily for about 11 months. Participants stay in the study for about one year, during which they visit the study site 16 times. At these visits, doctors check vision, document any health problems, and take detailed eye pictures. Researchers compare changes over time between the groups to evaluate if the treatment affects vision. The main outcome measured is whether participants gain at least 10 Early Treatment Diabetic Retinopathy Study ETDRS letters in vision at Week 48 compared to baseline.