FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in Exudative Age-related Macular Degeneration

Sponsor: Institut de la Macula y la Retina
Study ID: NCT01500915
Phase: PHASE4
Status: Completed

Conditions

Exudative Age-related Macular Degeneration

Eligibility Criteria

Sex: ALL
Age: 50 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Ranibizumab — DRUG
0,5mg intravitreal ranibizumab

Study Details

The purpose of this study is to investigate the safety and efficacy of a combined fixed-interval and a pro re nata (PRN) regimens of ranibizumab (FUSION regimen) for the treatment of exudative age-related macular degeneration (AMD) in patients with good visual acuity (VA) at baseline. To establish whether similar efficacy to monthly regimens can be achieved with fewer injections, even in patients with good VA.

Key Dates

First listed: Dec 29, 2011
Start date: Nov 30, 2010
Status verified: Mar 2015
Primary completion: Mar 31, 2012
Completion: Jul 31, 2012

Study Design

Enrollment: 17 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: ranibizumab

Primary Outcome Measure

mean VA change [ Time Frame: 12 months ]