drugset / Trial / NCT02259088
A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)
Timeline
- Start
- 2014-11-05
- Primary completion
- 2017-01-17
- Completion
- 2017-01-17
Outcome
Met primary endpoint
registry analysis (superiority or other test); Ranibizumab (RFB002) vs Laser; p <0.001; Least Squares Mean Difference 5.8 (95% CI 4.1 to 7.5); Cochran-Mantel-Haenszel NCT02259088 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |