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NIH study finds Avastin and Lucentis are equally effective in treating AMD
Date:4/28/2011

is as highly effective for the treatment of wet AMD. During the year between the announcement of the trial results and the release of Lucentis, ophthalmologists began injecting AMD patients with low doses of Avastin, due to its similarity to Lucentis and its availability. The FDA has not licensed Avastin for the treatment of AMD.

Numerous physicians noted a beneficial treatment effect and Avastin's use grew rapidly despite the lack of data on safety, efficacy and dosing from randomized clinical trials to support its use. Ophthalmologists used Avastin primarily as needed, or pro re nata (PRN), when there was evidence of active disease. The FDA approved Lucentis in 2006. However, most clinicians adopted PRN dosing for Lucentis, which was a departure from FDA-approved labeling and the monthly dosing schedule evaluated in the Genentech-sponsored clinical trials. It was not known if PRN dosing would produce the same long term vision benefits that were achieved with monthly administration.

NEI launched CATT in 2008 to compare Lucentis and Avastin for treatment of wet AMD. The study has now reported results for 1,185 patients treated at 43 clinical centers in the United States. Patients were randomly assigned and treated with one of four regimens for a year. They received Lucentis monthly or PRN, or Avastin monthly or PRN. Enrollment criteria required that study participants had active disease.

Patients in the monthly dosing groups received an initial treatment and then had an injection every 28 days. Patients in the PRN groups received an initial treatment and were then examined every 28 days to determine medical need for additional treatment. PRN groups received subsequent treatment when there were signs of disease activity, such as fluid in the retina. Ophthalmologists involved in patient care did not know which study drug a patient was getting, to make sure that the data was not affected by how anyone felt about the treatment.


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Contact: Jean Horrigan
jh@nei.nih.gov
301-496-5248
NIH/National Eye Institute
Source:Eurekalert

Page: 1 2 3 4

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