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OpenTrials
Completed

NCT Number: NCT01896284

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

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.

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Key information

Conditions

Wet Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Barcelona Macula Foundation

Barcelona, 08022, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.5mg aflibercept

Drug

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: week 12

  2. Changes in OCT central foveal thickness after loading dose

    Time frame: week 12

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

    Time frame: week 40

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

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

  5. Describe safety of this cohort of patients

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Barcelona Macula Foundation

Other

Collaborators

  • Bayer
  • TFS Trial Form Support

Registry information

Official study title

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.

Acronym: MACBETH

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 11, 2013
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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