NCT07812090RecruitingPhase 2
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 4 Sept 2026
- Start date
- 21 Aug 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- BioAge Labs, Inc.
- Diseases
- Diabetic eye disease
- NCT number
- NCT07812090
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 180
- From 21 Aug 2026 to the primary completion date, Nov 2027
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Age
- Macular edema in the study eye due to causes other than DME, such as retinal vein occlusion, uveitis, neovascular age-related macular degeneration
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.