Sulzbach Saar

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 long-term safety and tolerability of the Port Delivery System with ranibizumab PDS in people with neovascular age-related macular degeneration nAMD. This study includes participants who have completed earlier related studies or met specific criteria in a recent study. Two sub-studies are included one assessing the use of transscleral photocoagulation TPC to reduce vitreous hemorrhages after PDS implantation, and another evaluating the safety of re-implanting an updated PDS device. Participants will receive PDS implants and undergo refill-exchanges of ranibizumab at various intervals, mostly every 24 weeks Q24W, with some switching to every 12 weeks Q12W visits later in the study. The transscleral photocoagulation sub-study involves PDS implantation using TPC followed by ranibizumab refills. The re-implantation sub-study includes follow-up for up to 72 weeks after receiving the updated implant and scheduled refill-exchanges. During the study, participants will attend scheduled visits for treatment and assessments lasting up to several years. Researchers will monitor ocular and systemic adverse events, focusing on the severity and duration of side effects related to the device and treatment. Vision and eye health will be regularly evaluated using tests like best-corrected visual acuity and imaging. Safety data from the sub-studies will also be collected, including rates of vitreous hemorrhage and other ocular events, with study participation extending until regulatory decisions or study closure.

Researchers are evaluating the SING IMT prosthesis in patients aged 55 and older who have pseudophakic eyes eyes with implanted intraocular lenses and suffer from late-stage Age-Related Macular Degeneration AMD with moderate to profound bilateral central vision impairment. This international, randomized, multicenter study aims to expand the devices approved use and assess its safety and effectiveness in this specific patient group. The findings will support regulatory decisions, help clinical care, and may lead to label expansion for the device. The study involves two treatment approaches one where the SING IMT device replaces the existing intraocular lens IOL after removal Lens Exchange group, and another where the device is implanted in front of the existing IOL without removal Add-On group. Both procedures place the device in the sulcus area of the eye. Participants will be randomly assigned to one of these two groups. The trial includes multiple follow-up periods to assess outcomes after implantation. Participants will undergo vision tests and eye examinations at the start and then at 1, 3, and 6 months after the procedure. Key assessments include measuring the percentage of endothelial cell density ECD loss, visual acuity, and recording any surgical complications or adverse events. Patient-reported outcomes and the size of the incision needed for implantation will also be tracked. Participants are expected to engage in a postoperative training program for using the implant. The total study duration for each participant covers these assessments and monitoring visits.

This research aims to evaluate treatments for submacular haemorrhage SMH, a severe complication of wet age-related macular degeneration AMD that can cause significant and lasting vision loss. Wet AMD damages cells in the retinas central part called the macula, leading to abnormal blood vessel growth and fluid leakage. The study compares the current standard treatment using anti-VEGF eye injections to a combination of this treatment with surgery to see if vision can be improved further. Participants will be randomly assigned to one of two groups. One group will receive anti-VEGF injections alone, starting at baseline and continuing monthly for two doses, then every two months up to 12 months. The other group will have surgery involving vitrectomy to remove the eyes gel, an injection of a clot-breaking drug TPA, and a gas bubble placed inside the eye to help clear the blood clot, combined with the same anti-VEGF injection schedule starting at surgery. Surgery patients will follow specific head positioning instructions for five days post-operation and attend follow-up visits the day after surgery and one week later. Throughout the study, participants will have regular vision tests and clinical exams at baseline, 6 months, and 12 months, as well as ongoing anti-VEGF injections. Researchers will assess vision improvements using detailed visual acuity tests and questionnaires about visual function and quality of life. The study will monitor participants vision changes, side effects, and overall eye health over the one-year duration to determine whether surgery plus injections offers better outcomes than injections alone.