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

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.

• Oral BGE-102 (Drug): Capsules
• Oral Placebo Matching BGE-102 (Drug): Capsules
• Anti-VEGF (Drug): intravitreal injection
• Sham (Other): intravitreal injection

Primary outcomes

• Change in Best Corrected Visual Acuity (BCVA) [Week 12]: Change from Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) in the Study Eye

Secondary outcomes

• Incidence of serious adverse events (SAEs) [Up to Week 16]
• Incidence of treatment-emergent adverse events (TEAEs) [Up to Week 16]

Sex: All, ages: 18 Years to 75 Years

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