Clinical Trial

A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

Study acronym: BRUNELLO
Active, Not Recruiting Phase 2/3
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Summary
EYE-RES-102 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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2024-08-22; most recent amendment 2026-06-24.
Status change: Recruiting → Active, Not Recruiting 2025-07-01
Trial Details
NCT Number NCT06571045
Lead Sponsor EyeBiotech Ltd.
Conditions Diabetic Macular Edema (DME)
Enrollment 984 participants
Start Date 2024-08-07
Primary Completion 2026-09-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-26