NCT01918878

Aflibercept (EYLEA)as Secondary or Third Line Treatment for Neovascular Age-related Macular Degeneration.

A 7-month, Multicenter Study to Evaluate the Efficacy of Intravitreal Injections of Aflibercept (EYLEA) 2mg /0.05 ml as Secondary or Third Line Treatment for Neovascular Age-related Macular Degeneration (NVAMD).

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, single arm study. The study group will be compose of NVAMD patients who had partial or complete failure responding to initial bevacizumab or ranibizumab treatment of 3-6 monthly intravitreal injections. The patients in the study groups will receive 5 intravitreal injections of aflibercept 2mg/0.05ml at specific visits. Aflibercept will be provided for total period of 24 weeks.

Detailed description

The aim of this study is to prospectively evaluate the use of aflibercept in patients in whom initial incomplete response or loss of initial response for other intravitreal anti- vascular endothelial growth factor (anti-VEGF) therapy was demonstrated. This is a multi-center study initiated and conducted by the Israeli retina association. Each center participating in the study will follow the same protocol including standardized measurement of visual acuity, OCT, and Fluorescein angiography (FA). We will enroll 48 NVAMD patients which are partial or non-responded for 3-6 injections of intravitreal bevacizumab or ranibizumab and no more than one year of treatment . Test Treatment: Monthly intravitreal aflibercept 2mg /0.05 ml will be given at enrolment (day 0), 4 weeks, 8 weeks, 16 weeks, and 24 weeks after the initial enrollment for the study group. Follow-up period will be 28 weeks,7 visits. At the 28 week visit the primary and secondary end points will be evaluated.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Aflibercept (EYLEA)	INTARAVITREAL INJECTION OF AFLIBERCEPT

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2013-08-08
• Last updated: 2016-01-13

Locations

1 site across 1 country: Israel