Treat-and-extend regimen yields similar VA outcomes as subretinal fluid-resolving treatment
Patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab using a treat-and-extend (T&E) protocol and who have tolerated some subretinal fluid (SRF) appear to achieve visual acuity (VA) outcomes similar to that of treatment aimed at resolving all SRF, according to a study.
The phase IV, single-masked noninferiority clinical trial randomized 349 patients with treatment-naïve active subfoveal choroidal neovascularization (CNV) to receive ranibizumab 0.5 mg monthly until either complete resolution of SRF and intraretinal fluid (IRF; intensive arm: SRF intolerant; n=174) or resolution of all IRF only (relaxed arm: SRF tolerant except for SRF >200 μm at the foveal center; n=175) before extending treatment intervals.
Main outcomes of interest were mean change in best-corrected VA (BCVA), and central subfield thickness and number of injections from baseline to month 24. A 5-letter noninferiority margin was applied to BCVA.
Of the patients, 279 (79.9 percent) completed the study. The mean change in BCVA from baseline to month 24 was 3.0 letters in the intensive group and 2.6 letters in the relaxed group, demonstrating noninferiority of the relaxed treatment (p=0.99). Furthermore, there were no significant between-group differences observed in proportions of patients who achieved VA of 20/40 or better (53.5 percent vs 56.6 percent, respectively; p=0.92) and VA of 20/200 or worse (8.7 percent vs 8.1 percent; p=0.52).
The number of ranibizumab shots administered over 24 months was markedly fewer in the relaxed group than in the intensive group (mean, 15.8 vs 17; p=0.001).
Significantly more patients in the intensive group never extended beyond 4-week treatment intervals (13.5 percent vs 2.8 percent; p=0.003), whereas more patients in the relaxed group extended to and maintained 12-week treatment intervals (29.6 percent vs 15.0 percent; p 0.005).
The present data suggest that tolerating some SRF in nAMD patients treated with ranibizumab using a T&E protocol does not negatively impact VA outcomes, which are indeed comparable with that achieved with treatment aimed at resolving all SRF, researchers said.