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RECRUITING
NCT07812090
PHASE2

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

Sponsor: BioAge Labs, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-08-21

Completion Date

2027-12

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DRUG

Oral BGE-102

Capsules

DRUG

Oral Placebo Matching BGE-102

Capsules

DRUG

Anti-VEGF

intravitreal injection

OTHER

Sham

intravitreal injection

Locations (1)

Site 106

McAllen, Texas, United States