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
Sharma, Sumit; Toth, Cynthia A; Daniel, Ebenezer et al. (2016) Macular Morphology and Visual Acuity in the Second Year of the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology 123:865-75
Daniel, Ebenezer; Shaffer, James; Ying, Gui-shuang et al. (2016) Outcomes in Eyes with Retinal Angiomatous Proliferation in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). Ophthalmology 123:609-16
Shah, Neepa; Maguire, Maureen G; Martin, Daniel F et al. (2016) Angiographic Cystoid Macular Edema and Outcomes in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology 123:858-64
Ying, Gui-Shuang; Maguire, Maureen G; Daniel, Ebenezer et al. (2016) Association between Antiplatelet or Anticoagulant Drugs and Retinal or Subretinal Hemorrhage in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology 123:352-60
Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group; Maguire, Maureen G; Martin, Daniel F et al. (2016) Five-Year Outcomes with Anti-Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration: The Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology 123:1751-61
Meredith, Travis A; McCannel, Colin A; Barr, Charles et al. (2015) Postinjection endophthalmitis in the comparison of age-related macular degeneration treatments trials (CATT). Ophthalmology 122:817-21
Grunwald, Juan E; Pistilli, Maxwell; Ying, Gui-Shuang et al. (2015) Growth of geographic atrophy in the comparison of age-related macular degeneration treatments trials. Ophthalmology 122:809-16
Ciulla, Thomas A; Cuilla, Thomas A; Ying, Gui-Shuang et al. (2015) Influence of the Vitreomacular Interface on Treatment Outcomes in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology 122:1203-11
Hagstrom, Stephanie A; Ying, Gui-shuang; Maguire, Maureen G et al. (2015) VEGFR2 Gene Polymorphisms and Response to Anti-Vascular Endothelial Growth Factor Therapy in Age-Related Macular Degeneration. Ophthalmology 122:1563-8
Ying, Gui-shuang; Maguire, Maureen G; Daniel, Ebenezer et al. (2015) Association of Baseline Characteristics and Early Vision Response with 2-Year Vision Outcomes in the Comparison of AMD Treatments Trials (CATT). Ophthalmology 122:2523-31.e1

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