Binningen

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.

This research aims to predict which patients with early and intermediate age-related macular degeneration (AMD) may progress to advanced AMD, which causes irreversible vision loss, over a period of two years. The study focuses on identifying and measuring changes in the retina that relate to disease progression, assessing individual risk of progression using imaging techniques, understanding the sequence of events leading to advanced AMD, and improving AMD classification by combining artificial intelligence with traditional methods. Participants will be monitored for 24 months with check-ups every six months. During these visits, various eye imaging procedures will be performed, including Scanning Laser Fundus Photography, Color Fundus Photography, Optical Coherence Tomography, and Optical Coherence Tomography Angiography. No treatments will be given as part of the study; however, if treatments become approved in Europe during the study, patients may receive them according to their country's standard care outside the study. Throughout the study, participants will provide their medical history and undergo standard eye exams along with questionnaires about their visual function. Researchers will measure changes in the retina over time to identify those at risk for advancing AMD. The main outcome measured is the characterization and quantification of retinal changes using imaging over two years, helping to predict disease progression and improve monitoring methods.

Researchers are studying patients aged 55 to 99 years who have non-foveal, non-vision compromising atrophic age-related macular degeneration (AMD) to understand how the disease progresses over two years. The study aims to measure individual rates of progression, identify specific changes in the retina related to the disease, and assess the use of approved artificial intelligence (AI) algorithms in monitoring AMD progression. This is a prospective, multinational, multicenter observational study without any experimental treatment during the study period. Participants will be monitored every six months for 24 months using routine imaging techniques including Scanning Laser Fundus Photography, Color Fundus Photography, Optical Coherence Tomography (OCT), and Optical Coherence Tomography Angiography (OCTA). No treatments will be administered as part of the study; however, if treatments become approved in Europe, participants may receive them according to local standards of care outside the study. During each visit, patients will undergo standard eye exams and complete questionnaires about their visual function. Researchers will collect medical history and perform detailed retinal imaging to track disease progression. The main outcome is to characterize and quantify retinal changes to identify patients at risk for faster geographic atrophy progression. Participant involvement lasts for two years with regular assessments to monitor changes and safety.