Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor

Sponsor
Barcelona Macula Foundation
Study ID
NCT01896284
Phase
PHASE4
Status
Completed

Conditions

  • Wet Macular Degeneration

Eligibility Criteria

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

Interventions

  • 0.5mg aflibercept — DRUG
    0.5mg aflibercept intravitreal injection will be performed every 4 weeks from baseline to week 8 (3 doses) and every 8 weeks until week 32.

Study Details

Patients with neovascular age-related macular degeneration who do not respond to usual treatment with conventional medications may respond to a new drug of the same class which is designed to block a larger fraction of proangiogenic factors.

Key Dates

Start date
Jul 31, 2013
Status verified
Jul 2015
Primary completion
Nov 30, 2014
Completion
Jun 30, 2015

Study Design

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

Arms

  • Experimental: 0.5mg AFLIBERCEPT injection
    Patients will receive intravitreal injection of aflibercept 0.5mg at baseline, week 4,8,16,24 and 32. Optionally, if intra or subretinal fluid persists at week 12, patients will receive an additional injection.

Primary Outcome Measure

Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept [ Time Frame: Week 12 ]

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