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Ranibizumab treat-and-extend as effective as monthly injections in wet AMD
The CANTREAT trial found a treat-and-extend strategy with ranibizumab for patients with neovascular age-related macular degeneration was not worse than treatment with monthly injections after 2 years, according to a study.
“Our goal in treating macular degeneration, the most common cause of blindness in the Western world, is to maximize visual gains and minimize the burden of treatment and visits on patients and their families. This most recent Canadian Treat-and-Extend study (CANTREAT) publication shows definitively that patients randomized to a treat-and-extend regimen had similar outcomes to those randomized to monthly treatment at 24 months,” study co-author Peter J. Kertes, MD, CM, told Healio/OSN.
The trial included 580 patients who were randomly assigned to receive intravitreal Lucentis (ranibizumab 0.5 mg, Genentech) in either a treat-and-extend regimen or monthly dosing regimen. Researchers evaluated the mean change in best corrected visual acuity in ETDRS letters from baseline to 24 months as the primary outcome measure.
At 24 months, the treat-and-extend cohort gained 6.8 letters in BCVA compared with 6 letters in the monthly treatment cohort. The proportion of patients who gained less than 5 letters, including a loss of letters, at 24 months was 38.1% in the treat-and-extend cohort compared with 40.4% of patients in the monthly cohort. A gain of 15 or more letters was seen in 25.5% of patients in the treat-and-extend cohort compared with 23.1% in the monthly cohort.
Patients in the treat-and-extend cohort underwent a mean 17.6 injections over the 24-month period compared with 23.5 injections in the monthly cohort. – by Robert Linnehan
Disclosure : Kertes reports he receives grants, personal fees and nonfinancial support from Novartis; receives personal fees and nonfinancial support from Bayer; receives grants from Allergan and Roche; and holds stock in ArcticDx.
Perspective
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The 2-year results from the Canadian Treat-and-Extend Analysis Trial With Ranibizumab in Patients With Neovascular Age-Related Macular Disease (CANTREAT) study by Kertes and colleagues represent the strongest study evidence to date in support of the commonly used treat-and-extend (TAE) method of anti-VEGF therapy for neovascular age-related macular degeneration being noninferior to the gold standard of monthly ranibizumab treatment. The TAE approach for managing neovascular AMD has been commonly utilized in clinical practice for over a half a dozen years in the United States, Canada and elsewhere, but the evidence to definitely show that it has comparable visual outcomes to ranibizumab injected monthly as was performed in the pivotal clinical trials was limited to publications of mostly uncontrolled, retrospective studies until just a few years ago. The TREX neovascular AMD study was the first prospective, controlled trial to compare the two treatment regimens and show that TAE was noninferior to monthly injections, but it was a relatively small study. The larger TREND study out of Europe was the second prospective comparative trial to be published, and it also showed noninferiority of TAE to monthly injections, but the trial was limited to 1 year of follow-up. The CANTREAT study is both large in patient numbers and long in follow-up duration and serves to independently confirm the results of the other two studies. Therefore, together, these three studies represent very strong level one evidence that validates the use of the TAE approach as an alternative to fixed monthly injections in managing neovascular AMD in practice with anti-VEGF therapy.
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