Binningen

Researchers are exploring new treatment options for neovascular age-related macular degeneration NVAMD, a condition affecting the eyes. This trial aims to compare a new medicine called tiespectus also known as MK-8748 or EYE201 with the standard treatment aflibercept to see if tiespectus works as well in treating NVAMD. The study includes adults aged 50 and older who have not previously received treatment for this condition. Participants will be randomly assigned to one of three groups tiespectus low dose, tiespectus high dose, or aflibercept. Those in the tiespectus groups will receive three initial injections every 4 weeks, followed by injections every 8 weeks up to week 48. After week 48, treatment will continue at intervals based on individual response until week 92. The aflibercept group will receive three initial injections followed by injections every 8 weeks until week 92. During the study, participants will have their vision tested using the Best-Corrected Visual Acuity BCVA score and their eye structure examined with imaging techniques. Researchers will monitor changes in vision over one year and track any side effects up to approximately 96 weeks. Participants will attend regular visits for treatment and assessments throughout the study period lasting about 92 weeks.

Atrial fibrillation is the most common heart rhythm problem worldwide and increases the risk of heart failure, stroke, and death. Researchers expect its prevalence to rise, especially in people over 65 years old, with about one in three developing atrial fibrillation. Electrocardioversion is a procedure that restores normal heart rhythm but often results in the arrhythmia returning within a short time. This trial aims to study whether inflammation plays a role in this recurrence and if treating it can reduce the return of atrial fibrillation after electrocardioversion. The trial compares two groups one receives a daily oral dose of 0.5 mg Colchicine for three months, taken in the morning without a loading dose, alongside their usual treatments. The other group receives a matched placebo. This is a randomized, triple-blind Phase 3 study evaluating the effect of low-dose Colchicine on preventing atrial fibrillation recurrence after electrocardioversion. Participants will be monitored for recurrence of atrial fibrillation over six months following electrocardioversion. Researchers will assess the number of arrhythmia recurrences at one, three, and six months, the time to any repeat electrocardioversion, use of antiarrhythmic drugs, and hospitalizations. Safety and overall wellbeing will also be followed during this period, with the main outcome focused on arrhythmia recurrence within six months.

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 conducting a prospective, multinational, multicenter observational study to predict the progression from early and intermediate age-related macular degeneration AMD with functional vision to advanced AMD that causes irreversible vision loss over two years. The study aims to identify and measure specific changes in the retina related to disease progression, assess individual risk of advancing to severe AMD using imaging, clarify the sequence of events leading to advanced AMD, and improve AMD classification by using artificial intelligence alongside traditional methods. Participants will be monitored for 24 months with visits every six months. During these visits, researchers will perform non-invasive imaging tests including scanning laser fundus photography, color fundus photography, optical coherence tomography, and optical coherence tomography angiography. Participants will also provide medical history and complete standard eye exams and questionnaires about their vision. No treatments will be given as part of the study since no approved treatment is currently available in Europe, but if treatments become approved, patients may receive them as part of their usual care outside the study. Throughout the study, investigators will track retinal changes and disease progression using imaging and questionnaires. The main outcome is to characterize retinal alterations to identify patients at risk of developing advanced AMD. Secondary outcomes include identifying biomarkers of disease progression and evaluating the use of AI to monitor AMD. Safety and standard care will be maintained, and participants will be followed closely to understand AMD progression over time.

Researchers are conducting a prospective, multinational, multicenter observational study to assess and predict how non-foveal, non-vision compromising atrophic age-related macular degeneration AMD progresses in individual patients over two years. The study aims to measure the rate of progression, identify changes in the retina related to the disease, and evaluate the use of approved artificial intelligence AI algorithms to monitor AMD progression. This research is important as no treatment is currently approved in Europe for this condition. Participants will be followed for 24 months with check-ins every 6 months. During these visits, routine eye imaging tests will be performed, including Scanning Laser Fundus Photography, Color Fundus Photography, Optical Coherence Tomography, and Optical Coherence Tomography Angiography. Patients medical histories will be reviewed, and standard eye exams plus questionnaires about visual function will be completed. No specific treatment will be given as part of the study however, if a treatment becomes approved in the EU during the study, patients may receive it following standard care outside the study. Participants will undergo regular assessments focusing on imaging to characterize and quantify retinal changes linked to geographic atrophy progression. Researchers will use these images and AI tools to identify patients at risk for faster disease progression. Safety monitoring will continue throughout the 2-year period, and the study will collect data on disease progression biomarkers and AI monitoring effectiveness. This observational approach will help improve understanding of AMD progression without altering patient care during the study.