A randomised study to evaluate the Efficacy and Safety of Intravitreal EYE103 Compared to Anti-VEGF
Research type
Research Study
Full title
A Randomized, Double-masked, Multi-center, 3-Arm Pivotal Phase 2/3 Study to Evaluate the Efficacy and Safety of Intravitreal EYE103 Compared with Intravitreal ranibizumab (0.5mg) in Participants with Diabetic Macular Edema
IRAS ID
1011647
Contact name
Loni Da Silva
Contact email
Sponsor organisation
Eyebiotech Ltd.
Eudract number
2025-520809-12
Research summary
Diabetic Macular Edema (DME) is one of the most common causes of eyesight loss in working age adults and in individuals over 65\nyears old in developed countries. In patients with DME there is a collection of fluid in and under the centre of the retina (macula),\nwhich is the light-sensitive tissue at the back of your eye. Current treatment for DME includes injecting a protein in the eye called\nanti-vascular endothelial growth factor (anti-VEGF) therapy. However real-world clinical data suggests that for up to half of patients, these\ntreatments do not improve symptoms by much and do not prevent eyesight loss. EYE103 is a potential new treatment which may\nallow for reduction in leakage and improvement in visual outcomes compared to standard of care alone. The study is designed to assess\nnon-inferiority of the study drug (EYE103) compared with current treatment (ranibizumab). Approximately 960 patients will be\nenrolled in the study across 250 sites worldwide. The effectiveness of EYE103 will be assessed by measuring change in vision from\nthe beginning of the study until 104 weeks.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0061
Date of REC Opinion
1 Apr 2025
REC opinion
Further Information Favourable Opinion