Wake Forest

Researchers are studying intravitreal EYE103 in people with neovascular age-related macular degeneration (NVAMD) or macular edema after branch retinal vein occlusion (BRVO). This phase 2 randomized, dose-masked trial includes four patient groups, with participants randomly assigned to receive either a low or high dose of EYE103. Some groups include treatment-naïve participants, while others involve incomplete responders, including a group receiving EYE103 combined with aflibercept, a standard anti-VEGF medication. Participants will receive three injections of EYE103 in the study eye, spaced four weeks apart. Those in the combination therapy group will receive an additional aflibercept injection on the first day. The study will be conducted in sequential cohorts, with each group receiving their assigned treatment dose. Participants will have safety and effectiveness assessments at each injection visit, with some returning two weeks post-injection for extra evaluations. During the study, participants will undergo vision tests using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart and eye examinations such as slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT) to measure retinal thickness. The main outcome is the change in best-corrected visual acuity at week 12. The study concludes at the week 12 visit, which marks the end of participation for all enrolled individuals.

This research aims to assess the long-term safety and tolerability of JNJ-81201887, a medicine given by injection into the eye, in people with geographic atrophy secondary to age-related macular degeneration. The study includes participants who were previously treated in earlier clinical studies of this medicine. The main goal is to monitor any eye or systemic side effects and abnormal findings over up to five years. Participants who received low or high doses of JNJ-81201887 in earlier studies, as well as those initially given a sham procedure who may have later received the medicine, will join this extension study. No new treatments or injections will be given during this long-term study. It is designed as a randomized, triple-masked phase 2 trial to carefully observe participants over time. During the study, participants will have regular eye examinations, retinal imaging, and laboratory tests to check for any changes or adverse events related to the earlier treatment. Researchers will track ocular and systemic treatment-emergent adverse events for up to five years. Participants will be involved throughout this period with scheduled visits to monitor their condition and safety status consistently.

Researchers are studying the safety and effectiveness of intravitreal KSI-101 injections in adults with macular edema caused by inflammation, called Macular Edema Secondary to Inflammation (MESI). This Phase 3 clinical trial aims to evaluate how well KSI-101 works compared to a sham injection in improving vision for people with this condition. Participants will receive one of three treatments: KSI-101 at 5 mg or 10 mg doses injected into the eye every 4 weeks for six months, followed by dosing tailored to individual needs, or a sham injection following the same schedule. The study is randomized, double-masked, and controlled to ensure unbiased results. During the trial, participants will undergo vision tests to measure changes in best-corrected visual acuity (BCVA) over 24 weeks. Researchers will monitor safety and treatment effects throughout the study. The trial is expected to run until November 2027, with participants receiving regular assessments and follow-ups to track their eye health and response to treatment.

Researchers are conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of intravitreal KSI-101 in adults with macular edema caused by inflammation, known as Macular Edema Secondary to Inflammation (MESI). The study aims to understand how well this treatment works compared to a sham injection in improving vision and reducing eye swelling related to this condition. Participants are randomly assigned to receive one of three treatments: an intravitreal injection of KSI-101 at either 5 mg or 10 mg doses once every four weeks for six months, followed by personalized dosing schedules, or a sham injection on the same schedule. The injections are given directly into the eye, and the study is double-masked to ensure unbiased results. During the study, participants will undergo regular eye exams to measure visual acuity and eye thickness using specialized imaging. The main outcome is the change in best corrected visual acuity at 24 weeks. Researchers will also monitor the proportion of participants who show improvement in vision over this period. The trial includes safety assessments and will continue until August 2027, with detailed monitoring throughout the treatment and follow-up phases.

Researchers are evaluating how well different doses of a medicine called BI 3812465 are tolerated by adults with diabetic macular edema that affects the center of the eye. This is the first time BI 3812465 is given to humans. The study is designed in two parts: an initial phase with a small group receiving increasing doses and a second phase with a larger group randomized to low, medium, or high doses. Participants receive BI 3812465 as injections into the back of the eye, with a total of three eye injections administered. In Part 1, participants start with low doses and may move to higher doses if tolerated. In Part 2, participants are randomly assigned to one of three dose groups. The study follows participants for up to seven months, including the dosing and observation periods. During the study, participants visit the study site 19 times, with some visits possibly conducted at home when feasible. At these visits, doctors assess the severity of the eye condition and monitor any health problems that may be caused by the medicine. The main outcomes include monitoring for dose-limiting events and ocular adverse events over up to 169 days from the first drug administration.

Researchers are studying the effects of experimental drugs called pozelimab and cemdisiran on people with Geographic Atrophy (GA), a late stage of Age-related Macular Degeneration (AMD) that affects central vision. The trial aims to compare the rate at which GA progresses in patients receiving cemdisiran alone, pozelimab combined with cemdisiran, or a placebo. The study also explores possible side effects, how much of the drugs remain in the blood over time, and whether the body develops antibodies that might impact treatment. Participants are randomly assigned to one of three groups: one receiving both pozelimab and cemdisiran, one receiving cemdisiran alone, and one receiving a placebo. All treatments are given by subcutaneous injection. The study is conducted in a double-masked manner to ensure unbiased results. Vaccinations against meningococcal and pneumococcal infections are required before participation. During the study, participants will attend regular clinic visits where eye imaging and vision tests will be performed to monitor the size of GA lesions and changes in visual acuity. Blood samples will be taken to measure drug levels and antibody development. The primary outcome is the growth rate of GA lesion area over 52 weeks. Safety will be monitored throughout and up to nearly six years. The overall study duration allows detailed assessment of treatment effects and tolerability.

This research focuses on people with geographic atrophy caused by age-related macular degeneration (AMD). AMD damages the macula, the light-sensitive part of the retina, leading to worsening central vision. Geographic atrophy is an advanced form where retinal cells waste away, potentially causing permanent vision loss. The study observes how patients with this condition are treated in regular medical practice, especially those receiving avacincaptad pegol, a US-approved treatment for geographic atrophy. Participants in this observational study have already decided with their doctors to begin treatment with avacincaptad pegol via intravitreal injection. The study does not assign treatment but collects information on how this drug is used, monitoring patients over time. This includes tracking treatment patterns, safety, and any medical problems linked to avacincaptad pegol. The study runs for about five years, recording ongoing care and treatment decisions. During the study, participants will have routine eye exams and complete surveys about their eye health. Surveys occur at treatment start, every six months for two years, then annually. Researchers will gather data from medical records on the number and frequency of injections, treatment duration, reasons for stopping treatment, and patient characteristics. They will also monitor vision changes and adverse events. This long-term follow-up helps understand real-world use and safety of avacincaptad pegol in geographic atrophy care.

Researchers are evaluating the oral drug BI 1815368 in adults aged 18 and older who have centre-involved diabetic macular edema (CI-DME), a specific eye condition related to diabetes. The study aims to determine if BI 1815368 can improve vision in people with CI-DME and to find the most suitable dose. This is a phase 2, randomized, double-masked, placebo-controlled trial sponsored by Boehringer Ingelheim. The study has two parts. In the first part, participants are randomly divided into two equal groups: one group receives BI 1815368 tablets and the other receives placebo tablets that look like the study drug but contain no medicine. In the second part, participants are randomly assigned to one of four equal groups: three groups receive different daily doses of BI 1815368, and one group receives placebo. All participants take tablets twice daily for about 11 months. Participants will be involved in the study for about one year, attending 16 visits during this time. At each visit, doctors will check vision, take detailed eye images, and collect health information to monitor any problems. Researchers will compare changes in vision and eye measurements over time between groups to assess the study drug's effects and safety.

Researchers are evaluating the effectiveness of EYP-1901, a tyrosine kinase inhibitor, compared to Aflibercept in treating diabetic macular edema (DME). This phase 3, randomized, double-masked study aims to assess how well these treatments improve vision in participants with DME, a condition related to diabetic retinopathy that affects the central part of the retina. Participants will receive intravitreal injections of either EYP-1901 or Aflibercept. The study is designed with parallel groups and a quadruple masking approach, meaning neither participants nor researchers will know which treatment is given. The treatments will be administered according to the study schedule, with monitoring throughout the trial period. During the study, participants will undergo assessments including measuring best corrected visual acuity (BCVA) at 52 and 56 weeks to evaluate changes in vision. The study will also track the rate of injections needed by week 56. Safety and treatment effects will be monitored throughout the trial, which is expected to continue until October 2028.

Researchers are evaluating the safety and effectiveness of a gene therapy called Ixoberogene Soroparvovec (Ixo-vec) compared to a standard treatment called aflibercept in people with neovascular (wet) age-related macular degeneration (nAMD). This Phase 3 study involves participants who have not been treated before or have prior treatment experience. The study focuses on measuring changes in best corrected visual acuity (BCVA) at one year after treatment to see how well Ixo-vec works compared to aflibercept. Participants will receive either a single intravitreal injection of Ixo-vec or a series of injections of aflibercept. All participants get three monthly aflibercept doses as a loading phase, followed by either a single Ixo-vec injection at Week 1 with sham injections every 8 weeks, or sham injection at Week 1 with aflibercept injections every 8 weeks. This design allows comparison between the gene therapy and the active drug over a 56-week period. Throughout the study, participants will have regular eye exams to measure visual acuity and retinal thickness, and researchers will monitor safety and treatment effects. Assessments include visual function questionnaires and imaging to track changes in retinal anatomy. The study lasts more than a year, with key outcomes measured at Weeks 52 and 56. Safety, tolerability, and vision changes will be carefully reviewed during this time.