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

Barcelona Macula Foundation46 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wet Macular Degeneration

Interventions

0.5mg afliberceptDRUG

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Barcelona Macula Foundation

Barcelona, Spain

Outcomes

Primary Outcomes

Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept

At week 12 an OCT will be performed to evaluate the changes in intra or subretinal fluid and to determine the percentage of patients with no fluid after 3 doses of aflibercept injected on baseline visit, week 4 and week 8.

Time frame: Week 12

Secondary Outcomes

Changes in best corrected visual acuity (BCVA)after loading dose

Time frame: week 12

Changes in OCT central foveal thickness after loading dose

Time frame: week 12

Anatomic and Visual Acuity outcomes maintained during (every 8 weeks) treatment.

Time frame: week 40

Determine the time to resolution of any intra/sub retinal fluid on OCT

Time frame: week 4,8,12,24,32,40

Describe safety of this cohort of patients

Describe the safety of aflibercept in study patients by determining ocular and non ocular adverse events classified according to type, frequency and severity during 40 weeks

Time frame: baseline, week 4, 8, 12, 24, 32 and 40

Data from ClinicalTrials.gov

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