Diabetic Macular Edema (DME)
Conditions
Keywords
Diabetic Macular Edema, Diabetic Retinopathy, BGE-102, BioAge, NLRP3, Center-Involved
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.
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.
Interventions
Sponsors
BioAge Labs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The injecting clinician is unmasked
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) | Week 12 | Change from Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) in the Study Eye |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events (SAEs) | Up to Week 16 |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to Week 16 |
Countries
United States
Contacts
CONTACTCentral Recruiting
Outcome results
None listed