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

This study is currently recruiting participants.
Study NCT00593450.   Last updated on November 10, 2008.   Information provided by National Eye Institute (NEI)

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Descriptive Information Fields
Brief Title  Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
Official Title  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.

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Mean change in VA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Number of treatments [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
3-line change in VA (15 letters on ETDRS chart) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Change in subretinal and intraretinal fluid on optical coherent tomography [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Change in lesion size on fluorescein angiography [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Incidence of endophthalmitis, retinal detachment, cataract, uveitis [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]
Incidence of adverse events [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]
Cost [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Condition  Age Related Macular Degeneration
Intervention  Drug: ranibizumab
Drug: bevacizumab
MEDLINE PMIDs
Links Click here for more information about this study: Comparison of AMD Treatments Trials (CATT) This link exits the ClinicalTrials.gov site
NEI Clinical Studies Database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  1200
Start Date  February 2008
Completion Date February 2011
Eligibility 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
Gender Both
Ages 50 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Daniel F Martin, MD     (404) 778-4815     dan.martin@emory.edu    
Contact: Maureen G Maguire, PhD     (215) 615-1501     maguirem@mail.med.upenn.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00593450
Organization ID NEI-137
Secondary IDs †† U10 EY017823
Study Sponsor  National Eye Institute (NEI)
Collaborators ††
Investigators 
Study Chair:     Daniel F Martin, MD     Emory University    
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    
Information Provided By National Eye Institute (NEI)
Verification Date November 2008
First Received Date  January 3, 2008
Last Updated Date November 10, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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