drugset / Trial / NCT01846299

To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

NCT01846299 ↗

Phase 3 Completed 181 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

Summary

To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).

Timeline

Start
2013-10
Primary completion
2015-09
Completion
2015-09

Outcome

Met primary endpoint

registry analysis (superiority or other test); Ranibizumab vs Sham With Ranibizumab; p = 0.0111; Mean Difference (Net) 2.78 (95% CI 0.40 to 5.16); Mixed Models Analysis NCT01846299 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranibizumab Monoclonal antibody 0.5 mg Intravitreal

Indications