Overview
The purpose of this study is to learn about the effects of BGE-102 on change in vision in participants with center-involved diabetic macular edema (CI-DME). BGE-102 decreases inflammation which may improve vision or slow the progression of vison loss in those with CI-DME. Participants will be randomized to one of 3 arms and receive either BGE-102 in combination with an anti-vascular endothelial growth factor (anti-VEGF) drug, BGE-102 in combination with sham injection, or BGE-102 placebo in combination with an anti-VEGF drug. This study will also evaluate safety and tolerability of BGE-102.
Description
The purpose of this study is to assess the efficacy and safety of oral once a day (QD) dosing of BGE-102 alone or BGE-102 in combination with an anti-VEGF drug compared to anti-VEGF alone in participants with CI-DME on ocular parameters over 12 weeks of treatment.
Study details include:
- The study duration will be approximately 20 weeks (5 months) including the following study periods: screening (up to 4 weeks), treatment (12 weeks), and post treatment follow-up (4 weeks).
- The visit frequency will be every 2 weeks for the first 4 weeks of the treatment period and every 4 weeks thereafter up to Week 16.
- The treatment duration will be up to 12 weeks. BGE-102 will be given active, once daily capsules, or placebo, once daily capsules, in combination with anti-VEGF every four weeks intravitreal injection or sham injection for the entire 12-week treatment period.
Eligibility
Inclusion Criteria:
- Adults 18-75 years of age
- Type 1 or Type 2 Diabetes diagnosis
- Diabetic Macular Edema (DME) affecting the center of vision
- Study Eye may be treatment naïve (never received treatment) or previously treated and if previously treated, meets washout requirements
- Acceptable Vision as measured by an eye chart
- Visual Acuity and retinal thickness as measured by an eye scan, results meeting eligibility criteria
- Willing to use birth control, if applicable
Exclusion Criteria:
- Significant ocular disease, condition, or prior ocular treatment and/ or procedure that could affect vision, study assessments, or participant safety, including failure to meet required treatment washout periods
- Macular edema in the study eye due to causes other than DME, such as retinal vein occlusion, uveitis, neovascular age-related macular degeneration
- Significant macular ischemia in the study eye that would limit visual improvement as assessed by the Investigator and confirmed by the Reading Center
- Uncontrolled diabetes
- Uncontrolled blood pressure
- Medically unstable cardiac conditions and/or medically important ECG abnormalities.
- Relevant medical or psychiatric condition(s) that put the participant at risk or will make implementation of the protocol or interpretation of the study difficult.
- Women who are pregnant or nursing
