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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

2026-10-27

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 (16)

Site 104

Bakersfield, California, United States

Site 105

Glendale, California, United States

Site 118

Mountain View, California, United States

Site 128

Fort Myers, Florida, United States

Site 113

South Miami, Florida, United States

Site 119

West Monroe, Louisiana, United States

Site 117

Cary, North Carolina, United States

Site 116

Wake Forest, North Carolina, United States

Site 101

Ladson, South Carolina, United States

Site 111

Abilene, Texas, United States

Site 129

Austin, Texas, United States

Site 130

Houston, Texas, United States

Site 125

Laredo, Texas, United States

Site 106

McAllen, Texas, United States

Site 110

San Antonio, Texas, United States

Site 108

The Woodlands, Texas, United States