Ayer

Researchers are evaluating the effect of fenofibrate compared with placebo in preventing worsening of diabetic retinopathy (DR) over six years in people with mild to moderately severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) at the start. The study also aims to test a model where ophthalmologists collaborate with primary care providers like internists or endocrinologists to safely prescribe and monitor the drug. Additionally, the study will assess how blood sugar variability relates to DR outcomes and will include additional studies to understand functional and structural eye changes in participants. Participants will receive either fenofibrate or placebo daily with food, with the dose (either 160mg or 54mg) chosen based on kidney function measured at screening. The dose may be adjusted during follow-up according to the study protocol. The trial is randomized and includes a comparison between the fenofibrate and placebo groups. During the study, participants will be monitored for worsening of diabetic retinopathy over six years. Eye health will be assessed through specialized grading of fundus photographs and visual acuity tests. Kidney function and blood sugar variability will also be tracked. The main outcome measured is the progression of diabetic retinopathy. Researchers will observe safety and effectiveness while participants remain in the study for the full six-year period.

Researchers are evaluating two treatment strategies for neovascular age-related macular degeneration (nAMD), a condition that affects vision in people aged 50 and older. This Phase 3 trial compares a standard "Treat and Extend" (T&E) dosing schedule of anti-vascular endothelial growth factor therapy with a newer approach guided by home optical coherence tomography (OCT) imaging. The study aims to find out if daily home OCT monitoring can improve visual acuity outcomes and reduce the number of injections needed over a period of 104 weeks compared to the standard T&E approach. Participants receive intravitreal injections of 6 mg faricimab, either on a Treat and Extend schedule or guided by daily home OCT scans. At baseline, participants undergo vision tests, ocular exams, and imaging, followed by a faricimab injection. Those eligible for randomization are assigned to one of the two treatment groups. The T&E group returns for office visits every 4 to 18 weeks, while the home OCT group performs daily self-scans and only visits the clinic if fluid above a certain threshold is detected. The study follows participants for 104 weeks, with key visits at 52 and 104 weeks. Participants are involved in daily home OCT scanning if assigned to that group, attend scheduled visits for vision and imaging assessments, and undergo monitoring for treatment response and safety. Researchers measure changes in visual acuity using the E-ETDRS letter score and count the number of faricimab injections over the two-year period. The study also assesses adherence to daily scanning and evaluates treatment burden and outcomes for each approach to managing nAMD.

This research aims to improve understanding of the best timing for surgery in patients with symptomatic epiretinal membrane (ERM), a common condition affecting the macula in the eye. The study compares early vitrectomy surgery to remove the ERM versus delaying surgery until vision worsens, to see which approach leads to better visual outcomes. It also seeks to identify factors that predict outcomes after surgery or progression if surgery is deferred, and evaluates the usefulness of measures for visual distortion and reading speed in these patients. Participants will be randomly assigned to one of two groups: one receiving immediate vitrectomy surgery within one month of randomization to remove the ERM, and the other having deferred vitrectomy surgery only if certain vision loss criteria are met, symptoms worsen, or complications arise. Surgery is the main intervention, and the study will closely monitor participants over time to compare these approaches. Throughout the study, researchers will assess changes in visual acuity, distortion symptoms, and reading speed. Visual acuity letter scores will be measured from baseline up to 36 months to evaluate outcomes. Participants undergo regular eye exams and imaging to monitor the macula and ERM status, and their vision and symptoms are tracked to determine the best management approach. The study aims to provide detailed information on how timing of surgery affects vision and quality of life over three years.