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Actual outcomes of ranibizumab for nAMD inconsistent with trial results
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In studying ranibizumab therapy for eyes with neovascular age-related macular degeneration, researchers found that real-world treatment results were achieved with fewer injections and hospital visits than earlier research indicated.
The Writing Committee for the U.K. Age-Related Macular Degeneration EMR Users Group wrote in Ophthalmology that in a study of 92,976 treatment episodes from 12,951 eyes of 11,135 patients, the results they recorded differed from previous clinical trials.
Researchers collected data from 14 treatment centers using an electronic medical record (EMR) system for up to 5 years. The centers used ranibizumab to treat neovascular age-related macular degeneration (nAMD) using a loading phase of three monthly injections and a pro re nata retreatment regimen, as detailed in the study. Researchers recorded ages, Early Treatment Diabetic Retinopathy Study visual acuity (VA) and injection episodes.
Results showed that the mean age for first treatments was 79.1 years. They also showed that the percentage of patients that avoided moderate vision loss was 90% at 1 year, 84% at 2 years and 82% at 3 years.
The authors concluded in the abstract that the study provided pooled and anonymous data on the demographics, visual outcome, treatment and follow-up.
"Both baseline VA and age influence VA outcome and change in VA. This study supports the use of ranibizumab therapy at baseline VA better than that used in the entry criteria of randomized controlled clinical trials.
“The visual outcomes achieved in this real-world cohort are worse than those achieved in the randomized controlled clinical trials,” the authors continued. “It is likely that this is because of a combination of capacity constraints preventing intended monthly review at some centers, reduced treatment frequency and broader inclusion criteria (i.e., a different case mix) in the real world compared with clinical trials. EMR systems have the potential to collate very large volumes of data rapidly. This may enable retina specialist centers to benchmark their outcomes and facilitate cost-benefit analyses."
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Ophthalmology. 2014;doi: 10.1016/j.ophtha.2013.11.031.
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