A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Purpose
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.
Condition
- Diabetic Macular Edema (DME)
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- The injecting clinician is unmasked
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
McAllen, Texas 78503
More Details
- Status
- Recruiting
- Sponsor
- BioAge Labs, Inc.
Detailed Description
The purpose of this study is to assess the efficacy and safety of oral once a day (QD) dosing of BGE-102 alone or BGE-102 in combination with an anti-VEGF drug compared to anti-VEGF alone in participants with CI-DME on ocular parameters over 12 weeks of treatment. Study details include: - The study duration will be approximately 20 weeks (5 months) including the following study periods: screening (up to 4 weeks), treatment (12 weeks), and post treatment follow-up (4 weeks). - The visit frequency will be every 2 weeks for the first 4 weeks of the treatment period and every 4 weeks thereafter up to Week 16. - The treatment duration will be up to 12 weeks. BGE-102 will be given active, once daily capsules, or placebo, once daily capsules, in combination with anti-VEGF every four weeks intravitreal injection or sham injection for the entire 12-week treatment period.