ARGON NPDR
Research type
Research Study
Full title
A Phase 2 randomized, placebo-controlled, double-masked, dose-finding study to investigate the efficacy and safety of BAY3283142 in patients with moderately severe to severe non-proliferative diabetic retinopathy (ARGON-NPDR).
IRAS ID
1009575
Contact name
Markus Langen
Contact email
Sponsor organisation
Bayer AG
Research summary
Researchers are looking for a better way to treat people who have advanced diabetic eye disease (non proliferative diabetic retinopathy).
Diabetes is a condition characterized by excessive glucose, sugar, in the blood. This condition can damage organs of the body. The eyes of patients with diabetes are often affected by reduced blood flow to the retina. The retina is the structure in the back of eye that captures the light & sends signals to the brain so we can see.In diabetic eye disease, the blood vessels in the retina become leaky & change their shape. At this point, vision is still normal, but these changes can be seen by an eye doctor. As the disease progresses, more blood vessels & a larger area of the retina are affected. In later stages, new blood vessels might start growing in the retina or other parts of the eye.This stage is called ‘proliferative diabetic retinopathy’ & the earlier stages are called ‘non-proliferative diabetic retinopathy'.The main purpose of this study is to learn which dose level of BAY3283142 works better in improving the severity of diabetic retinopathy compared to placebo. A placebo looks like a study treatment but does not have any medicine in it. For this, researchers will count number of participants with at least 2 severity-level improvement in diabetic retinopathy severity scale in the study eye at Week 48 compared to the study start. In addition, researchers will investigate the safety of BAY3283142 in participants affected by non-proliferative diabetic retinopathy.Participants will be equally divided and randomly assigned to one of the 5 treatment groups:
- 4 groups of BAY3283142 based on different dose levels &
- a placebo group
Each participant will take 2 tablets once daily by mouth.Study doctors will regularly check participants’ health & vision.They will also take pictures of the inside of the eyes.Participants & researchers will not know who receives which treatment.A participant can be in the study for up to 1 year.REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0263
Date of REC Opinion
16 May 2024
REC opinion
Further Information Favourable Opinion