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

Part of paid clinical trials in McAllen, Texas.

Sponsor
BioAge Labs, Inc.
Study ID
NCT07812090
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Diabetic Macular Edema (DME)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Oral BGE-102 — DRUG
    Capsules
  • Oral Placebo Matching BGE-102 — DRUG
    Capsules
  • Anti-VEGF — DRUG
    intravitreal injection
  • Sham — OTHER
    intravitreal injection

Study Details

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.

Key Dates

First listed
Sep 10, 2026
Start date
Aug 21, 2026
Status verified
Sep 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Site 106McAllenTexas78503
Central Recruiting
[email protected]
866-331-7781

Related Studies