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A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema

BioAge Labs, Inc. · NCT07812090

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
180
US sites recruiting
1
Study start
August 21, 2026
Record last updated
September 10, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Oral BGE-102; Oral Placebo Matching BGE-102; Anti-VEGF; Sham

Conditions: Diabetic Macular Edema (DME)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Site 106

    McAllen, TX 78503

    Site contact: Central Recruiting · 866-331-7781 · bge102-004_inquiry@bioagelabs.com

Study contacts (from the official record)

  • Central Recruiting · 866-331-7781 · bge102-004_inquiry@bioagelabs.com
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A Randomized, Phase 2 Study of Oral BGE-102 in Participants With… (NCT07812090) | Bored Studies