In September, 2006, the National Eye Institute funded the Comparison of AMD Treatments Trials (CATT). This 4-arm, 1200 patient study was designed to determine the relative efficacy of Lucentis and Avastin and to evaluate their optimal dosing frequencies. Patient enrollment was planned to have begun in early 2007, however, regulatory hurdles including obtaining reimbursement for these agents by CMS extended the period of the trial beyond its current funding. In addition, it has become clear that the long term visual outcomes including safety and efficacy beyond two years are completely unknown. Given that Lucentis and Avastin are now the basis for virtually all AMD treatment worldwide and that these patients require continued dosing for many years beyond the previous periods of study, it is clear that the long term effects of these drugs must be understood. In this application, support for two initiatives is requested:
Specific Aim #1 : To complete the CATT: Lucentis-Avastin randomized clinical trial. The current period of funding ends August 2010. The last patient enrolled will complete their two year period of treatment in December 2011. Funding is requested to insure all patients are supported through completion of the first phase of the CATT study.
Specific Aim #2 : To conduct an observational Follow-up Study to investigate the course of visual acuity and the ocular and systemic safety of long-term treatment with Lucentis or Avastin. Patients who complete two years of treatment in the randomized clinical trial will be followed in an observational study for an additional three years.

Public Health Relevance

The development of Lucentis and Avastin represents a major therapeutic improvement over previous therapies for AMD and has profoundly altered expectations regarding the extent of visual loss that can be prevented or reversed. No single study has compared the safety and efficacy of these two agents head to head or looked at comparative outcomes of these agents using monthly or "as needed" dosing regimens.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY017828-08
Application #
8230741
Study Section
Special Emphasis Panel (ZEY1-VSN (01))
Program Officer
Redford, Maryann
Project Start
2006-09-30
Project End
2013-08-31
Budget Start
2012-02-01
Budget End
2013-01-31
Support Year
8
Fiscal Year
2012
Total Cost
$163,393
Indirect Cost
$153,686
Name
Cleveland Clinic Lerner
Department
Other Basic Sciences
Type
Schools of Medicine
DUNS #
135781701
City
Cleveland
State
OH
Country
United States
Zip Code
44195
Ying, Gui-shuang; Kim, Benjamin J; Maguire, Maureen G et al. (2014) Sustained visual acuity loss in the comparison of age-related macular degeneration treatments trials. JAMA Ophthalmol 132:915-21
Daniel, Ebenezer; Toth, Cynthia A; Grunwald, Juan E et al. (2014) Risk of scar in the comparison of age-related macular degeneration treatments trials. Ophthalmology 121:656-66
Folgar, Francisco A; Jaffe, Glenn J; Ying, Gui-Shuang et al. (2014) Comparison of optical coherence tomography assessments in the comparison of age-related macular degeneration treatments trials. Ophthalmology 121:1956-65
Hagstrom, Stephanie A; Ying, Gui-shuang; Pauer, Gayle J T et al. (2014) VEGFA and VEGFR2 gene polymorphisms and response to anti-vascular endothelial growth factor therapy: comparison of age-related macular degeneration treatments trials (CATT). JAMA Ophthalmol 132:521-7
Hagstrom, Stephanie A; Ying, Gui-Shuang; Pauer, Gayle J T et al. (2014) Endothelial PAS domain-containing protein 1 (EPAS1) gene polymorphisms and response to anti-VEGF therapy in the comparison of AMD treatments trials (CATT). Ophthalmology 121:1663-4.e1
Kim, Benjamin J; Ying, Gui-Shuang; Huang, Jiayan et al. (2014) Sporadic visual acuity loss in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). Am J Ophthalmol 158:128-135.e10
Gewaily, Dina Y; Grunwald, Juan E; Pistilli, Maxwell et al. (2014) Delayed patchy choroidal filling in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). Am J Ophthalmol 158:525-31.e2
Hagstrom, Stephanie A; Ying, Gui-Shuang; Pauer, Gayle J T et al. (2013) Pharmacogenetics for genes associated with age-related macular degeneration in the Comparison of AMD Treatments Trials (CATT). Ophthalmology 120:593-9
Jaffe, Glenn J; Martin, Daniel F; Toth, Cynthia A et al. (2013) Macular morphology and visual acuity in the comparison of age-related macular degeneration treatments trials. Ophthalmology 120:1860-70
Ying, Gui-shuang; Huang, Jiayan; Maguire, Maureen G et al. (2013) Baseline predictors for one-year visual outcomes with ranibizumab or bevacizumab for neovascular age-related macular degeneration. Ophthalmology 120:122-9

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