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A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Sponsor: BioAge Labs, Inc.
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
Conditions
Interventions
Oral BGE-102
Capsules
Oral Placebo Matching BGE-102
Capsules
Anti-VEGF
intravitreal injection
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