Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration (COLUMBUS-AMD)

NCT02611778 Phase 3 COMPLETED Results posted

The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration.

Details

Lead sponsor	Bioeq GmbH
Phase	Phase 3
Status	COMPLETED
Enrolment	712
Start date	2015-12-19
Completion	2018-06-06

Conditions

• Age-related Macular Degeneration (AMD)

Interventions

• ranibizumab

Primary outcomes

• Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 8 Weeks — Baseline and Week 8
  The primary endpoint was the absolute change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters after 2 months (8 weeks) of treatment.

Countries

Austria, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Russia, Spain, Ukraine, United Kingdom