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

Sponsor
Hadassah Medical Organization
Study ID
NCT01918878
Phase
PHASE4
Status
Unknown

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
Oct 31, 2013
Status verified
Sep 2015
Primary completion
Apr 30, 2016
Completion
Apr 30, 2016

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept (EYLEA)
    Intravitreal injection of aflibercept (EYLEA) 2mg/0.05ml at enrolment (day 0), 4 weeks, 8 weeks, 16 weeks and 24 weeks. Aflibercept will be provided for total period of 24 weeks

Primary Outcome Measure

Central macular thickness change [ Time Frame: at week 28 ]

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