Objective:
To evaluate the investigational oral NLRP3 inhibitor, BGE-102, in adults with diabetic macular edema (DME).
Approach:
- Trial Design: A Phase 2 randomized, controlled study enrolling approximately 180 participants.
- Treatment Groups: Participants will be randomized 1:1:1 to receive either intravitreal anti-VEGF plus oral placebo, intravitreal anti-VEGF plus BGE-102 90 mg once daily, or a sham intravitreal injection plus BGE-102 90 mg once daily.
- Duration: 12 weeks of oral treatment followed by four weeks of follow-up.
Key Findings:
- Primary endpoint is change from baseline in best-corrected visual acuity (BCVA) at week 12.
- Topline results are expected in the second half of 2027.
- BGE-102 is a novel small-molecule inhibitor targeting the NLRP3 inflammasome.
Limitations:
- The study is still ongoing, and results are not yet available.
Conclusion:
The dosing of the first participant marks a significant milestone for the QUELL-DME program.
Sources:
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