This clinical trial is focused on studying Diabetic Retinopathy, a condition that affects the eyes of people with diabetes, leading to vision problems. The study is testing a new treatment called COLIRIOBCN070660, which is an eye drop containing the active substance somatostatin. Somatostatin is a type of protein that may help reduce or stop the damage to small blood vessels in the eye caused by diabetic retinopathy. The purpose of the study is to evaluate how effective these eye drops are in treating patients with moderately severe to severe non-proliferative diabetic retinopathy, a stage of the disease where new blood vessels have not yet started to grow.
Participants in the study will be randomly assigned to receive either the COLIRIOBCN070660 eye drops or a placebo, which looks like the real treatment but does not contain the active substance. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. The treatment will be administered twice daily for one year. Throughout the study, the number of small bulges in the blood vessels of the eye, known as microaneurysms, will be monitored to see if the treatment is effective in reducing or stopping their formation.
In addition to monitoring microaneurysms, the study will also look at other factors such as the number of small bleeds in the eye, changes in the thickness of the retina, and overall eye health using various imaging techniques. The study aims to provide valuable information on whether COLIRIOBCN070660 can help improve or maintain vision in people with diabetic retinopathy, potentially offering a new treatment option for this common complication of diabetes.



Spain