Phase 1b Open-Label Study Evaluating Safety and Effects of Intravitreal THN391 for Diabetic Macular Edema in Diabetic Retinopathy

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of THN391 in people with diabetic macular edema DME related to non-proliferative diabetic retinopathy. This Phase 1b study focuses on how different doses of THN391 affect vision and retinal swelling in this eye condition. Participants will be enrolled into three groups receiving escalating doses of THN391 through intravitreal IVT injections. Each participant will receive three monthly injections of THN391 at low, medium, or high doses. The study is open-label and sequential, meaning all participants and researchers know the treatment given, and dosing increases with each group. During the study, participants will be monitored for adverse events for up to 16 weeks after their first injection. Researchers will also measure changes in visual acuity and retinal edema to assess treatment effects. Participation involves multiple visits for injections and assessments over approximately 4 months.

A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.