Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)

This Phase I study tests the safety and initial effectiveness of a new investigational drug called OCU200, given as an injection into the eye, for patients with center-involved diabetic macular edema (DME). Diabetic macular edema is the most common cause of vision loss in people with diabetes. It occurs when fluid leaks from damaged blood vessels in the central part of the retina (the macula), causing blurred and distorted central vision. While existing treatments using anti-VEGF injections (drugs that block abnormal blood vessel growth) work for many patients, a substantial proportion do not respond adequately and continue to lose vision. Eligible participants are adults with type 1 or type 2 diabetes who have DME involving the center of the macula causing reduced vision, with specific thicknesses on retinal scanning. Participants must have either never received anti-VEGF injections or received at least two injections without adequate improvement. People with uncontrolled blood pressure or diabetes, other eye conditions, recent eye surgery or injections, or advanced kidney disease are not eligible. Participants receive OCU200 injections and are monitored for changes in retinal thickness and visual acuity over several months, along with close safety monitoring. This research is important because new treatments for DME that work through different biological pathways than current drugs could rescue vision in the large group of patients who do not adequately respond to existing therapies — potentially preventing blindness in hundreds of thousands of people with diabetes worldwide.