September 22, 2017
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Treat-and-extend comparable to monthly injections in AMD

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A multicenter 12-month phase 3b study showed that treat-and-extend administration of ranibizumab is “statistically noninferior and clinically comparable” with monthly treatment in patients with neovascular age-related macular degeneration.

The TREND study recruited 650 treatment-naïve patients with active choroidal neovascularization secondary to AMD in 90 centers across 18 countries, randomly assigned to treat-and-extend or monthly ranibizumab 0.5 mg.

The treat-and-extend regimen consisted of a loading dose of two injections at baseline and after 1 month. The interval of subsequent visits was established based on disease activity, extending or shortening the intervals by 2 weeks.

The dosing regimen showed noninferiority to monthly treatment in improving visual acuity from baseline, with a mean improvement of 6.2 letters as compared with 8.1 letters in the monthly group. The visual gain was rapidly achieved over the first 6 months and remained stable until the end of the study in both groups. The visual improvement correlated positively with anatomic improvement in terms of reduced retinal central subfield thickness and decreased leakage.

Comparable results were obtained with fewer injections and fewer visits. Over 1 year, a mean of 8.7 vs. 11.1 injections were administered in the treat-and-extend group and monthly group, respectively, and the number of visits was 8.9 vs. 11.2.

As far as safety was concerned, adverse events were similar in both groups.

Several studies and a long experience with anti-VEGFs have shown that response to treatment and re-treatment requirements vary greatly among patients. According to the authors, “the [treat-and-extend] regimen considers these varying patient requirements, thus allowing for a tailored follow-up schedule.” – by Michela Cimberle

 

Disclosures: Silva reports he is a consultant to Allergan, Alimera, Alcon, Bayer, Novartis and Théa and receives financial support from Bayer, Alimera, Angelini, Théa, Allergan and Novartis. Please see the study for all other authors’ relevant financial disclosures.