Trial record 1 of 1 for:    NCT00593450
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Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Maureen Maguire, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00593450
First received: January 3, 2008
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.

A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.


Condition Intervention Phase
Age Related Macular Degeneration
Drug: ranibizumab
Drug: bevacizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Change From Baseline in Visual-acuity Score (Continuous) [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]

    Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline.

    In this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement.



Secondary Outcome Measures:
  • Change From Baseline Visual-acuity Score (Frequency) [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
  • Visual-acuity Score and Snellen Equivalent (Frequency) [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Visual-acuity Score and Snellen Equivalent (Continuous) [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]

    Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly.

    In this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity.


  • Number of Treatments [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Cumulative over the 1 year of trial

  • Average Cost of Drug/Patient [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Total Thickness at Fovea [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Total Thickness Change From Baseline at Fovea [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
  • Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
  • Fluid on Optical Coherence Tomography [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Dye Leakage on Angiogram [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Area of Lesion [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
  • Area of Lesion Change From Baseline [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
  • Change in Systolic Blood Pressure From Baseline [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]

Enrollment: 1208
Study Start Date: February 2008
Estimated Study Completion Date: November 2014
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
Drug: ranibizumab
• 0.5 mg (0.05 mL)intravitreal injection
Other Name: Lucentis
Experimental: 2
Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
Drug: bevacizumab
• 1.25 mg (0.05 mL)intravitreal injection
Other Name: Avastin
Experimental: 3
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Drug: ranibizumab
• 0.5 mg (0.05 mL)intravitreal injection
Other Name: Lucentis
Experimental: 4
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Drug: bevacizumab
• 1.25 mg (0.05 mL)intravitreal injection
Other Name: Avastin

Detailed Description:

Age related macular degeneration (AMD) is the leading cause of severe vision loss in people over the age of 65 in the United States and other Western countries. More than 1.6 million people in the US currently have one or both eyes affected by the advanced stage of AMD.

Lucentis® is the most effective treatment for neovascular AMD studied to date. Bevacizumab (Avastin®) and Lucentis® are derived from the same monoclonal antibody. Following the encouraging clinical trial results with Lucentis®, several investigators began evaluating intravitreal Avastin® for the treatment of CNV. Given its molecular similarity to Lucentis, its low cost, and its availability, the interest in Avastin® has been considerable. Avastin® has not been evaluated relative to Lucentis®.

In addition, previous studies do not answer the question of whether a reduced dosing schedule is as effective as a fixed schedule of monthly injections. Treatment dependent on clinical response has the potential to reduce the treatment burden to patients as well as to reduce the overall cost of therapy.

Only a single eye in each patient was analyzed.

At the five year follow-up visit, the subjects will undergo the same examinations and procedures as in the original study; however, the five year follow-up visit deos not involve any study treatment.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active, subfoveal choroidal neovascularization (CNV)
  • Fibrosis < 50% of total lesion area
  • Visual acuity (VA) 20/25-20/320
  • Age ≥ 50 yrs
  • At least 1 drusen (>63μ) in either eye or late AMD in fellow eye

Exclusion Criteria:

  • Previous treatment for CNV in study eye
  • Other progressive retinal disease likely to compromise VA
  • Contraindications to injections with Lucentis or Avastin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593450

  Hide Study Locations
Locations
United States, Arizona
Retina Consultants of Arizona
Mesa, Arizona, United States, 85210
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85064
Retina Associates Southwest, P.C.
Tucson, Arizona, United States, 85710
United States, California
California Retina Consultants
Bakersfield, California, United States, 93309
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
University of California-Davis Medical Center
Sacramento, California, United States, 95817
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States, 95819
West Coast Retina Medical Group, Inc.
San Francisco, California, United States, 94107
California Retinal Consultants
Santa Barbara, California, United States, 93103
West Coast Retina Medical Group, Inc.
Walnut Creek, California, United States, 94596
United States, Colorado
Colorado Retina Associates
Denver, Colorado, United States, 80457
United States, Florida
Retina Group of Florida
Fort Lauderdale, Florida, United States, 33334
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
United States, Georgia
Emory Eye Center
Atlanta, Georgia, United States, 30322
United States, Illinois
Illinois Retina Associates
Flossmoor, Illinois, United States, 60422
Ingalls Memorial Hospital/Illinois Retina Associates
Harvey, Illinois, United States, 60426
Illinois Retina Associates
Joliet, Illinois, United States, 60435
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46280
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Retina Associates of Kentucky
Lexington, Kentucky, United States, 40509
University of Louisville School of Medicine
Louisville, Kentucky, United States, 40202
United States, Maryland
Elman Retina Group, P.A.
Baltimore, Maryland, United States, 21237
The Retina Group of Washington
Chevy Chase, Maryland, United States, 20815
Retina Specialists
Towson, Maryland, United States, 21204
United States, Massachusetts
Opthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, United States, 02114
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States, 02459
United States, Michigan
Vision Research Foundation/Associated Retinal Consultants, P.C.
Grand Rapids, Michigan, United States, 49546
Vision Research Foundation/Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States, 48073
Vision research Foundation/Associated Retinal Consultants. P.C.
Traverse City, Michigan, United States, 49684
United States, Minnesota
VitreoRetinal Surgery
Edina, Minnesota, United States, 55435
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Barnes Retina Institute
St. Louis, Missouri, United States, 63110
United States, New Jersey
Retina Vitreous Center, PA
New Brunswick, New Jersey, United States, 08901
Retina Vitreous Center, PA
Toms River, New Jersey, United States, 08755
United States, New York
Long Island Vitreoretinal Consultants
Great Neck, New York, United States, 11021
Long Island Vitreoretinal Consultants
Riverhead, New York, United States, 11902
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Charlotte Eye, Ear, nose & Throat Associates
Charlotte, North Carolina, United States, 28210
Duke University Eye Center
Durham, North Carolina, United States, 27710
Charlotte Eye,Ear, Nose & Throat Associates
Monroe, North Carolina, United States, 28112
United States, Ohio
Retina Associates of Cleveland
Beachwood, Ohio, United States, 44122
Ohio State University Eye Physicians & Surgeons-Retina Division
Dublin, Ohio, United States, 43016
Retina Associates of Cleveland, Inc.
Lakewood, Ohio, United States, 44107
United States, Oklahoma
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Retina Northwest, P.C.
Portland, Oregon, United States, 97210
Casey Eye Institute
Portland, Oregon, United States, 97239
United States, Pennsylvania
Retina Diagnostic and Treatment Associates, LLC
Philadelphia, Pennsylvania, United States, 19107
Retina Vitreous Consultants
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Southeastern Retina Associates
Knoxville, Tennessee, United States, 37920
Southeastern Retina Associates
Knoxville, Tennessee, United States, 38909
Retina Vitreous Associates, P.C.
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Retina Associates
Arlington, Texas, United States, 76012
Texas Retina Associates
Dallas, Texas, United States, 75231
Retina and Vitreous of Texas
Houston, Texas, United States, 77025
Vitreoretinal Consultants
Houston, Texas, United States, 77030
United States, Virginia
The Retina Group of Washington
Fairfax, Virginia, United States, 22310
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Pennsylvania
Investigators
Study Chair: Daniel F Martin, MD The Cleveland Clinic
Study Chair: Stuart L Fine, MD Study Vice-Chair, University of Pennsylvania
Study Director: Maureen G Maguire, PhD Director of Coordinating Center, University of Pennsylvania
Study Director: Glenn Jaffe,, MD Director of OCT Reading Center, Duke University
Principal Investigator: Juan E Grunwald, MD Principal Investigator of Photography Reading Center, Universisty of Pennsylvania
  More Information

Additional Information:
Publications:
Martin DF, Maguire MG, Fine SL. Ranibizumab and bevacizumab for AMD. Authors reply. N Engl J Med 2011; 365:2237

Responsible Party: Maureen Maguire, Carolyn F. Jones Professor of Ophthalmology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00593450     History of Changes
Other Study ID Numbers: NEI-137, U10EY017823
Study First Received: January 3, 2008
Results First Received: June 18, 2012
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
bevacizumab
ranibizumab
choroidal neovascularization

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014