AMARONE
Research type
Research Study
Full title
A 2-part study consisting of an open-label multiple ascending dose (MAD) safety study, and a dose-finding single-masked comparative safety and preliminary efficacy study of intravitreal (IVT) EYE103 in a mixed population of participants with diabetic macular oedema (DMO) and neovascular age-related macular degeneration (NVAMD)
IRAS ID
1007826
Contact name
Loni Da Silva
Contact email
Sponsor organisation
Eyebiotech Limited.
Research summary
Diabetic Macular Oedema (DMO and Neovascular Age-Related Macular Degeneration (NVAMD) are the most common causes of eyesight loss in working age adults and in individuals over 65 years old in developed countries. In patients with DMO 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. In patients with NVAMD abnormal and leaking blood vessels cause changes and/or damage to the macular region. Current treatment for both DMO and NVAMD includes injecting a protein in the eye called anti-vascular endothelial 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 reduction in leakage and improvement in visual outcomes compared to standard of care alone. Part 1 of the study is designed to assess the safety of the study drug (EYE103) at 4 dose levels. Part 2 is designed to find the best dose for treatment of patients. Approximately 92 patients will be enrolled in the study across 70 sites worldwide. The effectiveness of EYE103 will be assessed by measuring the change in vision from the beginning of the study until 12 weeks.\n\nLay summary of study results: Injections of EYE103 into the eye were generally safe and well tolerated. Three monthly injections of EYE103 into the eye improved visual acuity and abnormal thickening of the retina (the light-sensitive tissue in the back of the eye) in patients with diabetic macular edema (DME). In a small group of patients with neovascular age-related macular degeneration (NVAMD), similar results were observed when injections of EYE103 were delivered alongside injections of aflibercept, a currently approved treatment for NVAMD.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0103
Date of REC Opinion
24 Jul 2023
REC opinion
Further Information Favourable Opinion