Study Comparing AVT29 and Eylea HD Injections for Treating Diabetic Macular Edema

What this Trial Is About

Researchers are evaluating the effectiveness and safety of AVT29 compared with Eylea HD in adults with diabetic macular edema DME. This randomized, double-masked, parallel-group, multicenter clinical study focuses on participants diagnosed with DME secondary to diabetes mellitus who have central involvement in the study eye. The trial aims to assess vision improvement and safety outcomes in this population. Participants will receive intravitreal IVT injections of either AVT29, a proposed aflibercept HD biosimilar, or Eylea HD aflibercept HD. Each participant will get one injection at the start of the study and additional injections every 4 weeks for two months at Week 4 and Week 8. After this initial period, injections will continue every 8 to 16 weeks based on diabetic retinopathy management criteria until the study ends. During the study, participants will be monitored for changes in best-corrected visual acuity BCVA using the ETDRS letter score, particularly from baseline to Week 8. Regular visits will involve eye exams and safety assessments. The total duration of participation depends on the study timeline, and the research team will carefully track vision changes and any treatment-related effects throughout the trial.

Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema