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Treat-and-extend regimen yields similar VA outcomes as subretinal fluid-resolving treatment

24 May 2019

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.

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Most Read Articles
Stephen Padilla, 04 Sep 2019
Use of sodium glucose cotransporter 2 (SGLT2), as compared with dipeptidyl peptidase 4 (DPP4), inhibitors appears to reduce the risk of heart failure and any-cause death without major cardiovascular events in the primary intention-to-treat analysis, according to a study.
Pearl Toh, 04 Sep 2019
More intensive LDL-lowering by adding ezetimibe to simvastatin in elderly individuals aged ≥75 years significantly reduced recurrent cardiovascular (CV) events without raising safety issues compared with simvastatin alone, a secondary analysis of the IMPROVE-IT* has shown.
27 Aug 2019
A once-weekly regimen of 25 mg trelagliptin is effective and safe for type 2 diabetes mellitus (T2DM) patients with severe renal impairment or end-stage renal disease, reports a new study.
Elvira Manzano, 2 days ago

The US Preventive Services Task Force (USPSTF), in an update of its 2013 recommendations, called on clinicians to offer risk-reducing medications to women who are at increased risk for breast cancer but at low risk for adverse effects.