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

NCT07812090 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BGE-102-004
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Best Corrected Visual Acuity (BCVA)

  Change from Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) in the Study Eye

  Week 12

Secondary Outcomes (2)

• Incidence of serious adverse events (SAEs)

  Up to Week 16

• Incidence of treatment-emergent adverse events (TEAEs)

  Up to Week 16

Study Arms (3)

Arm A: BGE-102 Monotherapy

EXPERIMENTAL

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

Drug: Oral BGE-102; Other: Sham

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

EXPERIMENTAL

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

Drug: Oral BGE-102; Drug: Anti-VEGF

Arm C: anti-VEGF Monotherapy

ACTIVE COMPARATOR

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

Drug: Oral Placebo Matching BGE-102; Drug: Anti-VEGF

Interventions

Oral BGE-102 DRUG

Capsules

Arm A: BGE-102 Monotherapy; Arm B: BGE-102 and anti-VEGF Combination Therapy

Oral Placebo Matching BGE-102 DRUG

Capsules

Arm C: anti-VEGF Monotherapy

Anti-VEGF DRUG

intravitreal injection

Arm B: BGE-102 and anti-VEGF Combination Therapy; Arm C: anti-VEGF Monotherapy

Sham OTHER

intravitreal injection

Arm A: BGE-102 Monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioAge Labs, Inc.: lead

Study Sites (1)

Site 106

McAllen, Texas, 78503, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Central Recruiting

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The injecting clinician is unmasked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: August 21, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)