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

Phase 4

Completed

• Conditions: Wet Macular Degeneration
• Interventions: Drug: 0.5mg aflibercept

• Registration Number: NCT01896284
• Lead Sponsor: Barcelona Macula Foundation

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 larger fraction of proangiogenic factors.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-11
• Primary Completion: 2014-11
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2018-11-21
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0.5mg AFLIBERCEPT injection	0.5mg aflibercept	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 Measures

Name	Time	Method
Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept	Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Changes in best corrected visual acuity (BCVA)after loading dose	week 12
Anatomic and Visual Acuity outcomes maintained during (every 8 weeks) treatment.	week 40
Changes in OCT central foveal thickness after loading dose	week 12
Determine the time to resolution of any intra/sub retinal fluid on OCT	week 4,8,12,24,32,40
Describe safety of this cohort of patients	baseline, week 4, 8, 12, 24, 32 and 40	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

Trial Locations

Locations (1)

Barcelona Macula Foundation; 🇪🇸 Barcelona, Spain