Historically, age-related macular degeneration (AMD) has been the leading cause of legal blindness throughout the western world. However, the prognosis for newly diagnosed patients improved dramatically in 2005 when the1-year results of randomized clinical trials showed that monthly injections of ranibizumab (Lucentis), a drug directed towards vascular endothelial growth factor (anti-VEGF), was highly effective in preserving visual acuity. While ranibizumab was in process for approval by the Food and Drug Administration, ophthalmologists adopted off label use of a closely related but untested drug, bevacizumab (Avastin) after observing immediate results on vision and retinal morphology similar to those with Lucentis. CATT, sponsored by the National Eye Institute, was initiated in 2008 to compare the efficacy and safety of the 2 drugs and to determine if less than monthly administration compromised vision. CATT 2-year results showed that the two drugs provided similar effects on vision and that patients treated monthly gained approximately one-half line more vision. While 2-year visual acuity was quite good, morphologic changes that could progress to damage vision were present in some eyes in all treatment groups The Comparison of AMD Treatment Trials (CATT) Follow-up Study will provide new information on the long-term (about 5 year) vision and morphologic outcomes for eyes of patients treated with anti-VEGF drugs. Patients who were enrolled and treated for 2 years for choroidal neovascularization within the CATT randomized clinical will return to one of 42 CATT clinical centers for measurement of visual acuity, optical coherent tomography (OCT), and fundus photography including fluorescein angiography. Previous large-scale clinical trials sponsored by industry have not provided reliable data on the long term effects of treatment. Nearly all patients in the United States with neovascular AMD are treated with anti-VEGF drugs and the long-term effects are extremely important to both patients and their ophthalmologists. Findings from the CATT Follow-up Study will provide patients and ophthlamologists with information on long- term results on vision and anatomic changes in eyes treated for neovascular AMD with anti-VEGF treatments.

Public Health Relevance

Findings from the CATT Follow-up Study will provide patients and ophthlamologists with information on long- term results on vision and anatomic changes in eyes treated for neovascular AMD with anti-VEGF treatments.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
1U10EY023530-01
Application #
8552314
Study Section
Special Emphasis Panel (ZEY1-VSN (03))
Program Officer
Redford, Maryann
Project Start
2013-09-30
Project End
2016-07-31
Budget Start
2013-09-30
Budget End
2014-07-31
Support Year
1
Fiscal Year
2013
Total Cost
$2,019,123
Indirect Cost
$641,194
Name
University of Pennsylvania
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
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