Testing oral BGE-102 for diabetic macular edema, alone or with eye injections
Tests oral BGE-102 in adults with diabetic macular edema affecting the center of the eye.
Plain-language title generated from the registry record
Registry title: A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Key facts
- Where
- Abilene, Austin, Bakersfield, Cary, Fort Myers, Glendale, Houston, Ladson, Laredo, McAllen, Mountain View, San Antonio, South Miami, The Woodlands, Wake Forest, and West Monroe, United StatesSee the 16 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07812090, who can take part
Where in United States
- AbileneAbilene, United StatesTaking people
- AustinAustin, United StatesTaking people
- BakersfieldBakersfield, United StatesTaking people
- CaryCary, United StatesTaking people
- Fort MyersFort Myers, United StatesTaking people
- GlendaleGlendale, United StatesTaking people
- HoustonHouston, United StatesTaking people
- LadsonLadson, United StatesTaking people
- LaredoLaredo, United StatesTaking people
- McAllenMcAllen, United StatesTaking people
- Mountain ViewMountain View, United StatesTaking people
- San AntonioSan Antonio, United StatesTaking people
- South MiamiSouth Miami, United StatesTaking people
- The WoodlandsThe Woodlands, United StatesTaking people
- Wake ForestWake Forest, United StatesTaking people
- West MonroeWest Monroe, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BioAge Labs, Inc.
- Trial code
- NCT07812090
- Record updated
- 27 October 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Uncontrolled diabetes; 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; 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 blood pressure; Women who are pregnant or nursing.