A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema

A Randomized, Double-Masked, Multicenter Phase 2 Study Evaluating the Efficacy, Safety, and Tolerability of Oral BGE-102 as Mono- and Combination Therapy in Participants With Center-Involved Diabetic Macular Edema

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.

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.

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