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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

Who can join

Ages 18 to 75 · All sexes

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

About the study

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.

What is being tested

• Oral BGE-102 (drug)
• Oral Placebo Matching BGE-102 (drug)
• Anti-VEGF (drug)
• Sham (other)

Sponsor: BioAge Labs, Inc. · Participants: 180 · Started: Aug 21, 2026

Contact the study team

• Central Recruiting · Phone: 866-331-7781

Official record on ClinicalTrials.gov — NCT07812090

Locations in the U.S.

Conditions

• Diabetic Eye Problems

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.