drugset / Trial / NCT01775124

Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration)

NCT01775124 ↗

Phase 4 Completed 332 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

Summary

The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.

Timeline

Start
2013-02-22
Primary completion
2015-11-23
Completion
2015-11-23

Outcome

Met primary endpoint

registry analysis (unspecified test); Ranibizumab 0.5 mg Monthly vs Ranibizumab 0.5 mg PRN; Mean Difference (Final Values) -1.6 (95% CI -2.95 to -0.2); ANOVA NCT01775124 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranibizumab Monoclonal antibody 0.5 mg Intravitreal