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Phase 2 Study of ENN0403 Capsules for Treating Diabetic Macular Edema Evaluating Two Dosages for Safety and Effectiveness
Led by EnnovaBio · Updated on 2025-02-21
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two doses of ENN0403 capsules in adults with diabetic macular edema DME, a condition causing vision loss due to swelling in the retina. This Phase 2, multicenter, randomized, parallel study will include about 60 participants to understand how well the drug works and how safe it is for people with DME. Participants will be randomly assigned to receive either a low dose or a high dose of ENN0403, taken orally once a day for 12 weeks. The study includes up to 2 weeks of screening to determine eligibility, followed by 12 weeks of treatment, and then a 2-week follow-up period, making the total study duration up to 16 weeks. During the study, researchers will measure changes in the thickness of the central retina CRT and visual acuity at various points, including weeks 4, 8, and 12. They will also monitor for any eye-related or other side effects. Participants will undergo regular assessments and tests to track these outcomes, ensuring close observation throughout the treatment and follow-up phases.
CONDITIONS
Brief Title
A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME
Research Team
L
Lei Huang
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