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

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: NCT00593450
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : August 30, 2012
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE January 3, 2008
First Posted Date  ICMJE January 15, 2008
Results First Submitted Date  ICMJE June 18, 2012
Results First Posted Date  ICMJE August 30, 2012
Last Update Posted Date August 21, 2017
Actual Study Start Date  ICMJE February 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2012)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2008)		 Mean change in VA [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2012)
  • Change From Baseline Visual-acuity Score (Frequency) [ Time Frame: Baseline and 1 Year ]
  • Visual-acuity Score and Snellen Equivalent (Frequency) [ Time Frame: 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.
  • Number of Treatments [ Time Frame: 1 Year ]
    Cumulative over the 1 year of trial
  • Average Cost of Drug/Patient [ Time Frame: at 1 Year ]
  • Total Thickness at Fovea [ Time Frame: at 1 Year ]
  • Total Thickness Change From Baseline at Fovea [ Time Frame: Baseline and 1 Year ]
  • Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea [ Time Frame: at 1 Year ]
  • Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea [ Time Frame: Baseline and 1 Year ]
  • Fluid on Optical Coherence Tomography [ Time Frame: at 1 Year ]
  • Dye Leakage on Angiogram [ Time Frame: at 1 Year ]
  • Area of Lesion [ Time Frame: at 1 Year ]
  • Area of Lesion Change From Baseline [ Time Frame: Baseline and 1 Year ]
  • Change in Systolic Blood Pressure From Baseline [ Time Frame: Baseline and 1 Year ]
  • Change in Diastolic Blood Pressure From Baseline [ Time Frame: Baseline and 1 Year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2008)
  • Number of treatments [ Time Frame: 12 and 24 months ]
  • 3-line change in VA (15 letters on ETDRS chart) [ Time Frame: 12 and 24 months ]
  • Change in subretinal and intraretinal fluid on optical coherent tomography [ Time Frame: 12 and 24 months ]
  • Change in lesion size on fluorescein angiography [ Time Frame: 12 and 24 months ]
  • Incidence of endophthalmitis, retinal detachment, cataract, uveitis [ Time Frame: 12 and 24 months ]
  • Incidence of adverse events [ Time Frame: 12 and 24 months ]
  • Cost [ Time Frame: 12 and 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
Official Title  ICMJE Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
Brief Summary

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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Age Related Macular Degeneration
Intervention  ICMJE
  • Drug: ranibizumab
    • 0.5 mg (0.05 mL)intravitreal injection
    Other Name: Lucentis
  • Drug: bevacizumab
    • 1.25 mg (0.05 mL)intravitreal injection
    Other Name: Avastin
Study Arms  ICMJE
  • 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.
    Intervention: Drug: ranibizumab
  • 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.
    Intervention: Drug: bevacizumab
  • 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.
    Intervention: Drug: ranibizumab
  • 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.
    Intervention: Drug: bevacizumab
Publications *

*   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: December 11, 2009)		 1208
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2008)		 1200
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00593450
Other Study ID Numbers  ICMJE NEI-137
U10EY017823 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Available at https://hyperprod.cceb.med.upenn.edu/catt/catt_index.php
Current Responsible Party University of Pennsylvania
Original Responsible Party Maryann Redford, DDS,Group Leader, Collaborative Clinical Research, National Eye Institute
Current Study Sponsor  ICMJE University of Pennsylvania
Original Study Sponsor  ICMJE National Eye Institute (NEI)
Collaborators  ICMJE National Eye Institute (NEI)
Investigators  ICMJE
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
PRS Account University of Pennsylvania
Verification Date July 2017

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