RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: BioAge Labs, Inc. • ClinicalTrials.gov ID: NCT07812090

Registry updated: 2026-09-10

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Description

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.

Interventions

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

Eligibility criteria

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

Conditions

Diabetic Macular Edema (DME)

Locations

Site 106 — McAllen, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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