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  • Treat-and-Extend for Wet AMD Garners More Support

    By Lynda Seminara
    Selected By: Stephen D. McLeod, MD

    Journal Highlights

    Ophthalmology, January 2018

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    Monthly injections of ranibizumab can improve best-corrected visual acuity (BCVA) outcomes in patients with neovascular age-related macular degen­eration (AMD), but the frequency of dosing can be inconvenient. Silva et al. compared monthly and treat-and-extend (T&E) protocols in patients with wet AMD and concluded that T&E was statistically noninferior and clinically comparable to monthly treat­ment for improving visual acuity.

    This 12-month phase 3 trial was conducted at 90 centers in 18 countries. The main objective was to demonstrate noninferiority of ranibizumab T&E, as measured by change in BCVA from baseline to study endpoint.

    Secondary outcome measures were safety, treatment exposure, and changes in retinal central subfield thickness (CSFT).

    Patients ≥ 50 years of age (mean age, 75.2 years; 55.4% women; 91.8% white) with newly diagnosed wet AMD were assigned randomly to receive ranibizumab 0.5 mg either according to a T&E regimen (n = 323) or monthly (n = 327). Demographics and baseline ocular characteristics were similar for the study groups.

    Approximately 90% of each group completed the study. At 12 months, the least-squares mean BCVA change from baseline reflected improvement of 6.2 letters with T&E and 8.1 letters with the monthly regimen (p < .001 for non­inferiority). Both groups had rapid gains in BCVA, primarily during the first 6 months, which continued throughout the study. Mean changes in CSFT were sim­ilar: 169.2 μm in the T&E group and 173.3 μm in the monthly group.

    The mean number of ranibizumab injections was lower in the T&E group (8.7, vs. 11.1 for those treated month­ly), as was the mean number of post­baseline visits (8.9 and 11.2, respective­ly). Types and rates of adverse events were similar.

    The authors concluded that the T&E approach is not inferior to the monthly regimen. Advantages of T&E include treatment individualization, fewer in­jections, less-frequent visits, and lower costs.

    The original article can be found here.