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

Barcelona Macula Foundation

Status and phase: Completed; Phase 4

Conditions: Wet Macular Degeneration

Treatments: Drug: 0.5mg aflibercept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01896284

BMF-AFLI-2013-01

2013-000848-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

0.5mg AFLIBERCEPT injection

Experimental group

Description:

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.

Treatment:

Drug: 0.5mg aflibercept