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

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.

NCT Number	NCT06957080
Lead Sponsor	EyeBiotech Ltd.
Conditions	Diabetic Macular Edema (DME)
Enrollment	1,054 participants
Start Date	2025-04-16
Primary Completion	2027-03-01 (estimated)
Study Completion	2028-03-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-26