CANTREAT bolsters evidence for treat-and-extend ranibizumab regimen in nAMD
medwireNews: Results of the randomised CANTREAT trial add to increasing evidence that a treat-and-extend (T&E) ranibizumab regimen results in similar visual outcomes, with fewer injections, than monthly treatment for neovascular age-related macular degeneration (nAMD).
The T&E approach “offers opportunities to individualize patient management while minimizing visit burden, risks, and associated costs with patient care”, say Peter Kertes (Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada) and co-investigators in Ophthalmology.
To address a need for “country-specific research to establish benchmarks upon which specific recommendations for the T&E approach can be developed”, Kertes and team recruited 526 Canadian patients with treatment-naïve nAMD to their prospective, open-label, multicentre study.
Participants were randomly assigned to receive intravitreal ranibizumab at a dose of 0.5 mg in either a standard monthly regimen (n=258) or a T&E (n=268) regimen.
Those in the T&E arm received monthly injections for a minimum of 3 months until there was evidence of disease stability. At the point of disease stability, the interval between injections was extended by 2 weeks up to a maximum of 12 weeks, or until a return to disease instability. Upon evidence of disease instability, the treatment interval was shortened by 2 weeks if the interval was 6 or 8 weeks, or by 4 weeks if the interval was 10 or 12 weeks until disease stability was regained.
At 12 months, the mean improvement in best-corrected visual acuity was 8.4 letters, from a baseline of 58.9 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters, in the T&E group and 6.0 letters, from a baseline of 59.5 ETDRS letters, in the monthly treatment group. This gave a mean difference of 2.4 letters, which was below the prespecified noninferiority margin of 5.0 letters, the researchers note.
The mean interval between injections at year 1 in the T&E group was 8.7 weeks, with more than two-thirds (69.3%) able to extend the treatment period to at least 8 weeks, and just under one-third (29.9%) able to extend to 12 weeks.
In line with this, patients in the T&E group received significantly fewer injections during the first 12 months of the study than those in the monthly treatment group, at a mean of 9.4 versus 11.8.
Kertes et al say that their findings support “individualizing the treatment of nAMD according to patient needs and disease characteristics and that one regimen does not fit all.”
They add that “the second year of the study will provide a more accurate indication of the number of injections and visual outcomes in patients treated with the T&E approach.”
The authors conclude: “The important question regarding the long-term benefits of T&E and implementation of an individualized regimen will become clearer with longer follow-up.”
By Laura Cowen
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