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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. |
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| 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. |
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| 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 ] |
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| Condition † | Age Related Macular Degeneration | ||||||||||||||||||||
| Intervention † | Drug: ranibizumab Drug: bevacizumab |
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| MEDLINE PMIDs | |||||||||||||||||||||
| Links | Click here for more information about this study: Comparison of AMD Treatments Trials (CATT) ![]() NEI Clinical Studies Database  ![]() |
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| Recruitment Information Fields | |||||||||||||||||||||
| Recruitment Status † | Recruiting | ||||||||||||||||||||
| Enrollment † | 1200 | ||||||||||||||||||||
| Start Date † | February 2008 | ||||||||||||||||||||
| Completion Date | February 2011 | ||||||||||||||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | 50 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts †† |
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| 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 † |
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| Information Provided By | National Eye Institute (NEI) | ||||||||||||||||||||
| Verification Date | November 2008 | ||||||||||||||||||||
| First Received Date † | January 3, 2008 | ||||||||||||||||||||
| Last Updated Date | November 10, 2008 | ||||||||||||||||||||