Status:
COMPLETED
Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor
Lead Sponsor:
Barcelona Macula Foundation
Collaborating Sponsors:
TFS Trial Form Support
Bayer
Conditions:
Wet Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Signed Informed Consent
- Men and women ≥ 50 years of age.
- Any choroidal neovascular membranes (CNVM) lesion (occult, minimally classic or classic) secondary to age-related macular degeneration
- Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25) in the study eye.
- Able to return for ALL clinic visits and complete all study-related procedures.
- Absence of other ocular diseases that could affect visual acuity.
- Patients without optimal response to ranibizumab or bevacizumab defined as:
- Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite at least 4 injections within last 6 months, being the last OCT with presence of fluid within the 6 weeks after last treatment with ranibizumab or bevacizumab.
- Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite three monthly treatment with ranibizumab or bevacizumab.
Exclusion
- No scar, fibrosis, or atrophy involving the center of the fovea
- No retina pigment epithelium (RPE) rip/tear involving the central fovea
- Participation in another simultaneous interventional clinical trial
- Prior treatment with anti-VEGF or steroids therapy in the study eye within 28 days of baseline
- Prior treatment with photodynamic therapy (PDT)
- Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- Active intraocular inflammation in the study eye
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
- Unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01896284
Start Date
July 1 2013
End Date
June 1 2015
Last Update
November 23 2018
Active Locations (1)
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1
Barcelona Macula Foundation
Barcelona, Spain, 08022