Trial | NCT01896284  Report issue

Title

Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor
Phase IV Study to Evaluate the Efficacy of Aflibercept in Subjects With Neovascular Age-related Macular Degeneration (wAMD), Without Optimal Response to Repeated Monthly Intravitreal Injections of Anti Vascular Endothelial Growth Factor (Anti VEGF-A) Therapy.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    aflibercept ...

  • Study Participants

    46
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.
Study Started
Jul 31
2013
Primary Completion
Nov 30
2014
Study Completion
Jun 30
2015
Last Update
Nov 23
2018

Drug 0.5mg aflibercept

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.

  • Other names: EYLEA

0.5mg AFLIBERCEPT injection Experimental

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.

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
No Results Posted