Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial

July 20, 2017 updated by: University of Pennsylvania

Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1208

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Visual-acuity Score (Continuous)
Time Frame: Baseline and 1 Year

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.
Baseline and 1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Visual-acuity Score (Frequency)
Time Frame: Baseline and 1 Year
Baseline and 1 Year
Visual-acuity Score and Snellen Equivalent (Frequency)
Time Frame: at 1 Year
at 1 Year
Visual-acuity Score and Snellen Equivalent (Continuous)
Time Frame: at 1 Year

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.
at 1 Year
Number of Treatments
Time Frame: 1 Year
Cumulative over the 1 year of trial
1 Year
Average Cost of Drug/Patient
Time Frame: at 1 Year
at 1 Year
Total Thickness at Fovea
Time Frame: at 1 Year
at 1 Year
Total Thickness Change From Baseline at Fovea
Time Frame: Baseline and 1 Year
Baseline and 1 Year
Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea
Time Frame: at 1 Year
at 1 Year
Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea
Time Frame: Baseline and 1 Year
Baseline and 1 Year
Fluid on Optical Coherence Tomography
Time Frame: at 1 Year
at 1 Year
Dye Leakage on Angiogram
Time Frame: at 1 Year
at 1 Year
Area of Lesion
Time Frame: at 1 Year
at 1 Year
Area of Lesion Change From Baseline
Time Frame: Baseline and 1 Year
Baseline and 1 Year
Change in Systolic Blood Pressure From Baseline
Time Frame: Baseline and 1 Year
Baseline and 1 Year
Change in Diastolic Blood Pressure From Baseline
Time Frame: Baseline and 1 Year
Baseline and 1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Eye Institute (NEI)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 3, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

July 20, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEI-137
  • U10EY017823 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available at https://hyperprod.cceb.med.upenn.edu/catt/catt_index.php

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe