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Treat-and-extend dosing reduces treatment burden in TREX-AMD trial
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CHICAGO — Treatment burden was significantly reduced with treat-and-extend dosing vs. monthly dosing of ranibizumab through 2 years in the TREX-AMD study, an investigator reported here.
Charles C. Wykoff , MD, PhD, presented the study results at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting. The trial was funded by a grant from Genentech.
Charles C. Wykoff
The objective of a treat-and-extend approach to wet AMD management is to individualize dosing in order to minimize treatment burden while optimizing vision benefit, Wykoff said.
In the multicenter prospective TREX-AMD trial, 60 treatment-naive eyes with wet age-related macular degeneration were randomized 1:2, with 20 eyes receiving monthly ranibizumab treatment and 40 receiving treat-and-extend ranibizumab. TREX eyes were given monthly dosing for at least 3 months until achieving a dry macula, then injection intervals were incrementally increased to a maximum of 12 weeks.
Sixty-eight percent of the TREX arm achieved a dry macula and intervals were extended following three or four injections; 8% of TREX eyes never achieved a dry macula.
Regarding treatment burden through 2 years, a statistically significant difference between the two groups was seen, with the TREX group receiving a mean of 18.6 injections and the monthly group receiving a mean of 25.5 injections (P <.0001).
Regarding mean change in visual acuity, “Both the monthly and the TREX arms performed well, gaining a mean 10.5 and 8.7 letters, respectively, with no significant differences between the groups,” Wykoff said. However, whereas 20% of the monthly arm and 28% of the TREX arm gained at least 15 letters and no eyes in the monthly arm lost 15 letters of visual acuity, 10% of eyes in the TREX group did lose 15 letters or more. Wykoff associated the vision loss with progressive macular atrophy as a contributing factor.
“Importantly, no patient lost vision due to exudative disease recurrence while the interval between treatments was extended,” Wykoff said. – by Patricia Nale, ELS
Reference:
Wykoff C. Monthly vs treat and extend for neovascular AMD: TREX-AMD 24-month outcomes. Presented at: American Academy of Ophthalmology annual meeting; Oct. 14-18, 2016; Chicago.
Disclosure: Wykoff reports he is a consultant for Allergan, Alimera, Bayer, Clearside, DORC, Genentech, ONL Therapeutics and Regeneron, is a speaker for Allergan and Regeneron, and receives research support from Acucela, Alcon/Novartis, Alimera, Allergan, Apellis, Clearside, DORC, DRCR.net, Genentech/Roche, Iconic, Ophthotech, Santen, Regeneron/Bayer, Thrombogenics and Tyrogenex. The study was funded by a grant from Genentech.