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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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 larger fraction of proangiogenic factors.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barcelona Macula Foundation
• Collaborators: Bayer; TFS Trial Form Support
• Treatments: Aflibercept; Endothelial Growth Factors; Mitogens

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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