Strathfield

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.

Researchers are evaluating the long-term safety and tolerability of JNJ-81201887, given as an intravitreal injection a shot into the eye, in participants with Geographic Atrophy GA secondary to Age-related Macular Degeneration AMD. This study is a long-term extension of parent clinical trials where participants had previously received either low or high doses of JNJ-81201887 or a sham procedure. The goal is to monitor participants over an extended period to understand any lasting treatment effects or side effects. Participants entering this long-term extension study will not receive additional doses of the study drug or any new intervention as part of this trial. They previously participated in parent studies where they were treated with either low dose or high dose JNJ-81201887 or sham procedure. Some participants who were in the sham group of the parent study may receive open-label treatment outside this study before entering this extension. This study focuses solely on follow-up without new treatment administration. Throughout the study, participants will undergo regular assessments to monitor ocular and systemic safety. These include tracking treatment-emergent adverse events, clinical laboratory tests, retinal imaging, and eye examinations over up to five years. This extended monitoring aims to evaluate the long-term safety profile of the previous treatments. Participants will be followed with periodic visits and evaluations, with the total study duration extending until 2030.

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 FWY003 in adults aged 50 and older with geographic atrophy GA caused by age-related macular degeneration AMD. The study aims to understand the relationship between different doses of FWY003 and their effects on the size of GA lesions, as well as the safety and overall effectiveness of the treatment compared to a placebo. This is a randomized, multi-center, double-masked Phase 2 trial designed to gather detailed information about dosing and outcomes. Participants are randomly assigned to one of four groups receiving either one of three dose levels of FWY003 or a placebo. The treatment period lasts 18 months, during which doses are administered and monitored regularly. The study includes extensive assessments of visual function using various eye tests and imaging to measure changes in GA lesion areas. Blood samples are also collected to measure FWY003 levels. Throughout the study, participants undergo periodic evaluations including eye exams, imaging, and visual acuity tests to track changes in their condition and monitor for any adverse effects. Safety is closely observed from the first dose through month 19. The primary measurement is the change in GA lesion size over 18 months. Participants are followed for the full duration of the trial, which lasts until 2029, ensuring comprehensive monitoring of treatment effects and safety.

Researchers are evaluating the safety and effectiveness of a single intravitreal injection of 4D-150 in adults aged 50 and older with macular neovascularization caused by neovascular age-related macular degeneration nAMD. This Phase 3 trial compares 4D-150 to an active control treatment, aflibercept, to better understand how these treatments affect vision and eye health in this condition. Participants are randomly assigned to receive either one dose of 4D-150 or aflibercept injections at scheduled visits. The 4D-150 is given as a single intravitreal injection on Day 1, while aflibercept is administered during follow-up visits as needed. The study includes a 52-week period to assess visual changes and a longer 104-week period to monitor the need for additional aflibercept injections and other eye health measures. During the study, participants will undergo eye exams including measurements of visual acuity using the ETDRS letter score and evaluations of the central subfield thickness in the retina. Researchers will track the number and timing of aflibercept injections and monitor any anatomical or functional changes in the treated eye. Safety and stability of vision will be observed throughout the trial period, which lasts up to two years.