Recruiting
Phase 2

BGE-102 with Anti-VEGF

Sponsor:

BioAge Labs, Inc.

Code:

NCT07812090

Conditions

Diabetic Macular Edema (DME)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Oral BGE-102

Oral Placebo Matching BGE-102

Anti-VEGF

Sham

Study Details

Brief 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.

Conditions

Diabetic Macular Edema (DME)

Study ID

NCT07812090

Start date

Aug 21, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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
  • 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 diabetes
  • Uncontrolled blood pressure
  • 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.
  • Women who are pregnant or nursing

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: BGE-102 Monotherapy

BGE-102 Capsules dosed once daily in combination with Sham intravitreal injection delivered every 4 weeks

experimental: Arm B: BGE-102 and anti-VEGF Combination Therapy

BGE-102 Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks

active comparator: Arm C: anti-VEGF Monotherapy

Placebo Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks

Interventions

Oral BGE-102

Capsules

Oral Placebo Matching BGE-102

Capsules

Anti-VEGF

intravitreal injection

Sham

intravitreal injection

Primary outcome measure

  • Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Central Recruiting

866-331-7781bge102-004_inquiry@bioagelabs.com

Locations

Site 106

Recruiting

McAllen, Texas, United States, 78503

Contacts

Central Recruiting

866-331-7781bge102-004_inquiry@bioagelabs.com

More Information

Sponsor

BioAge Labs, Inc.

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Keywords

  • Diabetic Macular Edema
  • Diabetic Retinopathy
  • BGE-102
  • BioAge
  • NLRP3
  • Center-Involved

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by BioAge Labs, Inc. on 2026-09-10.