A randomised study to evaluate the Efficacy and Safety of Intravitreal EYE103 Compared to Anti-VEGF
Research type
Research Study
Full title
A Randomised, 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
1010164
Contact name
Loni Da Silva
Contact email
Sponsor organisation
Eyebiotech Ltd.
Eudract number
2024-510944-30
Clinicaltrials.gov Identifier
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 years old in developed countries. In patients with DME there is a collection of fluid in and under the centre of the retina (macula), which is the light-sensitive tissue at the back of your eye. Current treatment for DME includes injecting a protein in the eye called anti-vascular\nendothelial growth factor (anti-VEGF) therapy. However real-world clinical data suggests that for up to half of patients, these treatments do not improve symptoms by much and do not prevent eyesight loss. EYE103 is a potential new treatment which may allow for\nreduction in leakage and improvement in visual outcomes compared to standard of care alone. The study is designed to assess non-inferiority of the study drug (EYE103) compared with current treatment (ranibizumab). Approximately 960 patients will be enrolled in the study across 200 sites worldwide. The effectiveness of EYE103 will be assessed by measuring change in vision from the beginning of the study until 104 weeks.
REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0529
Date of REC Opinion
29 Aug 2024
REC opinion
Further Information Favourable Opinion