Sulzbach Saar

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) at 100 mg/mL in people with neovascular age-related macular degeneration (nAMD). This study includes participants who have completed previous Phase II or Phase III studies or reached Week 24 in a related study but were not randomized. The study also explores two sub-studies: one assessing a laser treatment to reduce eye bleeding related to the PDS implant procedure, and another assessing the safety of re-implanting an updated PDS device. Participants receive the PDS implant with ranibizumab according to specific schedules in their study arms. The first sub-study uses transscleral photocoagulation with an Iridex laser system to reduce vitreous hemorrhages after implantation, enrolling about 55 participants. The second sub-study involves up to 100 participants in the United States who undergo re-implantation of the updated device and are followed for up to 72 weeks. Treatments and procedures are carefully monitored throughout. Participants undergo regular visits for up to 240 weeks to monitor for adverse events, including eye-related and systemic effects, severity, duration, and any device-related issues. The sub-studies also track specific complications like vitreous hemorrhages and adverse device effects during postoperative and follow-up periods. Safety assessments include eye exams, imaging, and evaluation of systemic health to ensure ongoing monitoring of participant well-being throughout the study.

Researchers are evaluating the SING IMT12 prosthesis in patients aged 55 and older who have late-stage Age-Related Macular Degeneration (AMD) with bilateral central vision impairment and have previously undergone cataract surgery with intraocular lens (IOL) implantation. This international, randomized, multicenter study aims to assess the safety and effectiveness of the device in pseudophakic patients. The findings will support regulatory decisions, clinical guidance, and possible expansion of the device's approved use. Participants will be randomly assigned to one of two procedures: either the existing IOL will be removed and replaced with the SING IMT12 device implanted in the sulcus (Lens-Exchange group), or the SING IMT12 device will be implanted in front of the existing IOL in the sulcus (Add-on group). Both procedures involve surgical implantation of the device designed to improve vision in this patient group. During the study, participants will be monitored for endothelial cell density (ECD) loss at baseline, and then at 1, 3, and 6 months after surgery. Assessments will include vision tests, evaluation of peripheral vision, and follow-up visits to monitor safety and device performance. Participants will also take part in a postoperative training program to learn how to use the SING IMT12 implant effectively. Total study duration and detailed follow-up procedures will support thorough evaluation of treatment outcomes and safety.

The trial investigates treatments for wet age-related macular degeneration (AMD) complicated by submacular haemorrhage (SMH), a serious condition where bleeding under the retina can cause severe and lasting vision loss. Wet AMD causes abnormal blood vessels to grow and leak fluid in the eye's macula, damaging the central vision used for activities like reading and recognizing faces. This phase 3 study compares the standard anti-VEGF injection treatment alone to anti-VEGF injections combined with surgery, aiming to find out if the addition of surgery improves vision outcomes. Participants are randomly assigned to one of two groups. The first group receives standard care with intravitreal aflibercept injections starting at baseline, then monthly for two months, followed by injections every two months up to one year. The second group receives the same injection schedule alongside surgery involving vitrectomy (removal of the eye's gel), injection of a clot-dissolving drug (TPA) under the retina, and gas insertion to help clear the blood clot. Surgery patients follow specific head positioning for five days post-operation to aid healing. Follow-ups include clinical exams and vision tests at 6 and 12 months, with injections continuing as scheduled. During the study, participants undergo vision assessments including the Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score to measure best-corrected visual acuity. Safety and treatment effects are monitored throughout the 12-month period. Surgery patients have additional follow-up visits the day after and one week post-surgery. The goal is to evaluate if combining surgery with standard anti-VEGF injections leads to better preservation or improvement of vision compared to injections alone.