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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

Tracking Information
First Submitted Date  ICMJE July 8, 2013
First Posted Date  ICMJE July 11, 2013
Last Update Posted Date November 23, 2018
Actual Study Start Date  ICMJE July 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2013)
  • 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 [ 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Wet Macular Degeneration
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: 0.5mg aflibercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2018)
46
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2013)
43
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01896284
Other Study ID Numbers  ICMJE BMF-AFLI-2013-01
2013-000848-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barcelona Macula Foundation
Study Sponsor  ICMJE Barcelona Macula Foundation
Collaborators  ICMJE
  • TFS Trial Form Support
  • Bayer
Investigators  ICMJE
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
PRS Account Barcelona Macula Foundation
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP