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Mimi Liu, Pin-wen Wang, Zdenka Haskova; Individualized ranibizumab dosing effective for maintaining visual acuity gains in patients with BRVO and CRVO. Invest. Ophthalmol. Vis. Sci. 2016;57(12):4163.
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© ARVO (1962-2015); The Authors (2016-present)
The SHORE study established the efficacy of individualized as needed (PRN) ranibizumab (RBZ) injections (inj) for the treatment of macular edema secondary to RVO. This retrospective analysis of SHORE data examined visual acuity (VA) outcomes according to the number of RBZ inj received post randomization in patients (pts) with RVO treated with PRN dosing.
SHORE was a 15-month, phase IV, randomized study that evaluated monthly versus PRN dosing of RBZ in 202 pts with branch RVO (n=115) and central RVO (n=87). From months (M) 0-6, pts received 7 monthly RBZ 0.5 mg inj. Between M7 and M14, pts continued to receive monthly RBZ inj until the first month at which pre-specified VA and spectral-domain OCT stability criteria were met. Pts were then randomized to continue RBZ monthly (n=85) or switched to a PRN regimen (n=86). Pts who were never randomized (dropped out or did not meet stability criteria prior to M14) continued on monthly treatment (n=31). VA outcomes by RBZ inj number in PRN pts were retrospectively analyzed herein.
In the PRN arm, 80.2% (69/86) of pts were randomized by M8. Within this population, 24.6% of pts received 0-1 RBZ inj post randomization, 52.2% received 2-4 RBZ inj, and 23.2% received ≥5 RBZ inj. The average number of RBZ inj post randomization in these pts was 3.2. Overall, pts randomized to the PRN arm had best-corrected VA (BCVA) gains from baseline at M15 consistent with pts randomized to the monthly treatment arm (+21.0 vs +18.7 letters). At M15, pts randomized by M8 who received fewer RBZ inj post randomization had a greater improvement from baseline in BCVA compared with pts who received a greater number of RBZ inj following randomization (+27.3, +19.5, and +19.3 letters in pts who received 0-1, 2-4, and ≥5 RBZ inj post randomization, respectively), indicating a heterogeneous response to anti-VEGF treatment among these pts with RVO.
In SHORE, after achieving disease stability following 7 or more monthly RBZ inj, the majority of pts maintained significant VA gains with less than monthly RBZ inj. The treatment benefits of less than monthly dosing and monthly dosing were comparable. Thus, disease stability-driven individualized treatment with RBZ is a practical approach for treating pts with macular edema secondary to RVO that can help to ensure maximal treatment benefit while minimizing the burden of treatment.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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