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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01896284
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : November 23, 2018
Sponsor:
Collaborators:
TFS Trial Form Support
Bayer
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Wet Macular Degeneration Drug: 0.5mg aflibercept Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : July 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.5mg AFLIBERCEPT injection
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.
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 Name: EYLEA




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896284


Locations
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Spain
Barcelona Macula Foundation
Barcelona, Spain, 08022
Sponsors and Collaborators
Barcelona Macula Foundation
TFS Trial Form Support
Bayer
Investigators
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Principal Investigator: Jordi Mones, MD PhD Barcelona Macula Foundation
Principal Investigator: Carlos Juan Donate, MD Hospital Clínico San Carlos
Principal Investigator: Marta Suárez de Figueroa, MD Hosipital Universitario Ramon y Cajal
Principal Investigator: Jose Luis Olea, MD Hospital Son Espases
Principal Investigator: Francisco Cabrera, MD Hospital Universitario Insular de Canarias
Principal Investigator: Laura Sarasols, MD Hospital Universitari General de Catalunya
Principal Investigator: Javier Araiz, MD Instituto Clínico Quirúrgico de Oftalmología de Bilbao
Principal Investigator: Jose Maria Ruiz-Moreno, MD Hospital Universitario de Albacete
Principal Investigator: Ignasi Jürgens, MD PhD Institut Catala de Retina

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Responsible Party: Barcelona Macula Foundation
ClinicalTrials.gov Identifier: NCT01896284    
Other Study ID Numbers: BMF-AFLI-2013-01
2013-000848-26 ( EudraCT Number )
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: July 2015
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs