A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

Summary

EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME). In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm. Approximately 960 participants will be entered in the study.

Timeline

Start

2025-04-16

Primary completion

2027-03-01

Completion

2028-03-30

Drugs

Indications