NCT01500915

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

FUSION Regimen: A Disease Activity Guided Treatment Algorithm With Ranibizumab in naïve Subjects With Exudative Age-related Macular Degeneration

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Institut de la Macula y la Retina · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, open-label, consecutive interventional case series in treatment-naïve patients with exudative AMD. A loading phase of 2-3 injections is followed by a fixed-interval regimen of injections combined with a pro re nata regimen for 12 months. Endpoints include VA, presence of fluid at spectral domain optical coherent tomography (SD-OCT), adverse events and number of injections administered.

Conditions

• Exudative Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Ranibizumab	0,5mg intravitreal ranibizumab

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-03-01
• Completion: 2012-07-01
• First posted: 2011-12-29
• Last updated: 2015-03-24

Locations

1 site across 1 country: Spain