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Two of the most commonly used treatments for neovascular AMD, ranibizumab (Lucentis, Genentech), approved in 2006 by FDA, and the other commonly used ?off-label,? bevacizumab (Avastin, Genentech), resulted in similar improvements in visual acuity, according to a new randomized controlled trial published in NEJM.
Two of the most commonly used treatments for neovascular age-related macular degeneration (AMD), ranibizumab (Lucentis, Genentech), approved in 2006 by FDA, and the other commonly used ‘off-label,’ bevacizumab (Avastin, Genentech), resulted in similar improvements in visual acuity, according to a new randomized controlled trial published online and ahead of print in NEJM.
AMD is the leading cause of legal blindness in people aged 65 and older. There are 2 forms of AMD, wet (also referred to as neovascular) and dry. While all cases begin as the dry form, 10% to 15% will progress to the wet form, which can result in severe central vision loss. It is estimated that more than 1.7 million Americans suffer from neovascular AMD.
In this most recent clinical trial, researchers randomly assigned 1,208 patients with neovascular AMD to receive intravitreal injections of ranibizumab 0.50 mg or bevacizumab 1.25 mg on either a monthly schedule (considered standard-of-care) or on an as needed basis with monthly evaluation.
After 1 year of follow up, patients treated with bevacizumab administered monthly (n=286) experienced similar improvement in visual acuity (8.0±15.8 letters gained on an eye chart) to those receiving ranibizumab administered monthly (n=301; 8.5±14.1 letters gained). Similarly, bevacizumab administered as needed (n=300) was found to be equivalent to ranibizumab (n=298) as needed (5.9±15.7 vs 6.8±13.1 letters gained, respectively). When equivalency in injection scheduling was evaluated (monthly vs as needed), no difference in visual acuity with ranibizumab was observed. The same could not be conclusively said of bevacizumab (neither noninferiority nor inferiority could be established between the 2 groups).
Due to the finding of equivalency between the 2 agents, the researchers suggested that cost be an important consideration in choosing an agent.
“A single dose of ranibizumab costs 40 times as much as a single dose of bevacizumab,” noted the researchers. They continued, “This cost differential has important economic implications when extrapolated to the more than 250,000 patients who are treated for neovascular AMD annually in the United States.”
The average per patient cost of a drug for in the entire 1 year of the trial was $23,400 for ranibizumab monthly, $13,800 for ranibizumab as needed, $595 for bevacizumab monthly, and $385 for bevacizumab as needed.
This trial, dubbed ‘Comparison of Age-Related Macular Degeneration Treatments Trials (or CATT) was funded by the National Eye Institute of the National Institutes of Health.