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ARRA Investments in Age-related Macular Degeneration: Comparative Effectiveness Research

Public Health Burden
Age-related macular degeneration (AMD) is a leading cause of visual impairment and blindness among older Americans. Nearly two million Americans are visually impaired by AMD, and more than seven million are at increased risk of vision loss from the disease. AMD can severely restrict mobility and independence. AMD affects the macula, the central part of the retina that allows one to see fine detail. In the early stages of the disease, fatty deposits called drusen accumulate in the macula. As the disease progresses, abnormal, leaky blood vessels grow and damage the light-sensitive retina.

Comparative Effectiveness Studies
Comparative effectiveness studies compare the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions. Such studies can provide information on the relative strengths and weaknesses of various medical interventions and help clinicians and patients make treatment decisions.

NIH-supported research has established that the protein, vascular endothelial growth factor (VEGF), spurs the blood vessel growth in AMD. In June 2006, the Food and Drug Administration approved the drug Lucentis (ranibizumab), a VEGF inhibitor, developed for treating advanced AMD. Lucentis is chemically very similar to Avastin (bevacizumab), a VEGF inhibitor that is FDA-approved for colon and lung cancer. Lucentis costs approximately $2000 per dose and repeated injections are needed. Avastin is $50 per dose. Avastin has become widely used off-label as an alternative to Lucentis; however, there have been no clinical trials to evaluate Avastin in AMD. To address this issue, the NIH is currently conducting the Comparison of AMD Treatments Trial (CATT) , to compare the safety and effectiveness of these two drugs. If Avastin were found to be equivalent to Lucentis, the cost savings to patients, Medicare and private health insurance companies would be enormous. CATT began recruiting patients in 2008 and is expected to be completed in 2011.
  • The CATT trial received additional funding through ARRA to enhance the timeliness of Adverse Event reporting which is in excess of the amount originally projected. ARRA funds will also go toward incorporation of an improved retinal image analysis method that provides higher resolution images to better gauge outcome measures in this trial.

  1. U10EY017823—Coordinating Center for CATT—Maguire, Maureen (PA)
  2. U10EY017825—CATT Retina OCT Reading Center—Jaffe, Glenn (NC)

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