NCT07812090 · BioAge Labs, Inc.
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
(QUELL-DME)
What this 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.
View original scientific description
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.
Interventions
DRUG
Oral BGE-102
Capsules
DRUG
Oral Placebo Matching BGE-102
Capsules
DRUG
Anti-VEGF
intravitreal injection
OTHER
Sham
intravitreal injection
Primary outcome measures
Change in Best Corrected Visual Acuity (BCVA)
Time frame: Week 12
Change from Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) in the Study Eye
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- McAllen, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 10, 2026 · Source of record for eligibility and locations