Burlington

Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.

Researchers are evaluating the safety and effectiveness of belzupacap sarotalocan (bel-sar) compared to a sham control in patients with primary indeterminate lesions or small choroidal melanoma. This is a Phase 3 randomized, masked, controlled trial aiming to provide clear evidence on bel-sar's use in these eye conditions. The study focuses on patients without metastatic disease who have not previously been treated for their lesions, except possibly with photodynamic therapy. Participants receive bel-sar through a suprachoroidal injection using a specialized microinjector, followed by activation with an infrared laser. The control group undergoes similar procedures with sham devices and sham laser application to maintain masking. The trial is carefully designed to keep patients, assessors, and sponsors unaware of the treatment assignments to ensure unbiased results. Throughout the study, researchers will monitor the time it takes for tumors to progress, up to 65 weeks. Participants will undergo imaging and clinical evaluations to track safety and tumor status. The trial's structured follow-up includes assessments for any adverse effects and effectiveness of the treatment, helping to determine bel-sar's role in managing these eye tumors.

Researchers are evaluating the safety and lasting effects of AR-14034 Sustained Release (SR) implant in people with neovascular age-related macular degeneration (nAMD). This study has two stages, starting with a dose-escalation phase to assess safety and preliminary effects, followed by a randomized comparison with an approved treatment called aflibercept. The trial is designed as a Phase 1/2 study to better understand how well AR-14034 SR works and how long its benefits last compared to standard therapy. In Stage 1, about 10 participants will receive one of two dose levels of AR-14034 SR via an intravitreal implant and be followed for 48 weeks to monitor safety and early treatment response. In Stage 2, approximately 130 participants will be randomly assigned to one of three groups: one injection of AR-14034 SR, two injections of AR-14034 SR, or aflibercept injections as currently labeled. This stage lasts 56 weeks, followed by a 16-week open-label extension phase where participants continue to be observed. Participants will attend multiple visits throughout the study to assess visual acuity using standard eye charts and monitor safety. Researchers will collect data at baseline, Week 44, and Week 48 to measure changes in vision. Additional assessments include eye exams and evaluations for any side effects during and after treatment. The total duration for participants ranges from 48 to 72 weeks depending on the stage and extension phase involved.