Diabetic Macular Edema study: Oral BGE-102 vs Anti-VEGF
Official title A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
ClinicalTrials.gov ID: NCT07812090
What this study is testing
What is BGE-102?
an investigational oral capsule being studied as a potential treatment for diabetic macular edema (DME).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether BGE-102 can change vision in people with center‑involved diabetic macular edema.
- Who it's for
- You may be able to join if you have center‑involved diabetic macular edema.
- What's involved
- You will take an oral BGE-102 pill. You might also get a real anti‑VEGF eye injection, a pretend injection, or a placebo pill, depending on chance, like a coin toss. The study will check how your vision changes and how safe the pill is.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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
You likely can't join if
- Significant ocular disease, condition, or prior ocular treatment and/ or procedure that could affect vision, study assessments, or participant...
- 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Bakersfield, California, United States
- Glendale, California, United States
- Mountain View, California, United States
- Fort Myers, Florida, United States
- South Miami, Florida, United States
- West Monroe, Louisiana, United States
- Cary, North Carolina, United States
- Wake Forest, North Carolina, United States
- Ladson, South Carolina, United States
- Abilene, Texas, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Laredo, Texas, United States
- McAllen, Texas, United States
- San Antonio, Texas, United States
- The Woodlands, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bakersfield, California, United States; Glendale, California, United States; Mountain View, California, United States; Fort Myers, Florida, United States; South Miami, Florida, United States; West Monroe, Louisiana, United States and 10 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.