Oral BGE-102 for center-involved diabetic macular edema (Phase 2)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 study compares BGE-102 given once daily alone or with an anti-VEGF injection or placebo with anti-VEGF, in adults with center-involved DME. Participants are assigned to three arms and followed for about 12 weeks of treatment plus screening and a follow-up period over roughly 20 weeks. Assessments focus on vision changes and ocular measurements, along with safety and tolerability of BGE-102.

Why it matters

Who can join: the full rules

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 it's running

• Site 104
  Bakersfield, California, United States Recruiting
• Site 105
  Glendale, California, United States Recruiting
• Site 118
  Mountain View, California, United States Recruiting
• Site 128
  Fort Myers, Florida, United States Recruiting
• Site 113
  South Miami, Florida, United States Recruiting
• Site 119
  West Monroe, Louisiana, United States Recruiting

Study contacts

• Study coordinator: Central Recruiting
• Email: bge102-004_inquiry@bioagelabs.com
• Phone: 866-331-7781

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Oral N-Acetylcysteine for Diabetic Macular Edema

  This study tests whether taking N-acetylcysteine by mouth can help people with center-involving diabetic macular edema who don’t yet need anti-VEGF therapy.

  Recruiting Phase 2 Tanta University · Damietta · NCT07917338

• 4D-150 gene therapy injected into the eye for adults with diabetic macular edema

  This study tests whether a one-time intravitreal injection of 4D-150 can help adults with diabetic macular edema compare to aflibercept.

  Recruiting at 23 sites Phase 3 4D Molecular Therapeutics · Scottsdale, Arizona and 93 other locations · NCT07867080

• Corticosteroid for Diabetic Macular Edema (DME) in Adults with Diabetic Retinopathy

  This trial tests whether intravitreal corticosteroid injections can influence inflammatory biomarkers and improve DME in adults with type 2 diabetes.

  Recruiting Phase 4 Vanderbilt University Medical Center · Nashville, Tennessee · NCT07843849

• Tabirafusp Tedromer vs Aflibercept for Diabetic Macular Edema (DME)

  This study tests whether Tabirafusp Tedromer can work as well as or better than Aflibercept to help people with Diabetic Macular Edema.

  Recruiting at 52 sites Phase 3 Kodiak Sciences Inc · Scottsdale, Arizona and 51 other locations · NCT07734844

• Early imaging changes with faricimab versus biosimilar ranibizumab for diabetic retinal disease

  This trial will see if faricimab or a biosimilar ranibizumab causes different early OCT and OCTA imaging changes in adults with diabetic retinopathy or diabetic macular edema who need anti-VEGF injections.

  Recruiting Osijek University Hospital · Osijek · NCT07520045

• Comparing BAT5906 and Lucentis for diabetic macular edema

  This test will see if BAT5906 works as well as Lucentis to improve vision in adults with diabetic macular edema.

  Recruiting at 47 sites Phase 3 Bio-Thera Solutions · Beijing, Beijing Municipality and 49 other locations · NCT07515079

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.