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Mimi Liu, Pin-wen Wang, Zdenka Haskova; Baseline predictors of early visual acuity improvement in RVO patients treated with ranibizumab in the SHORE study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5802.
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© ARVO (1962-2015); The Authors (2016-present)
To identify baseline (BL) predictors of early improvement of visual acuity (VA) in patients with branch or central retinal vein occlusion (RVO) treated with ranibizumab (RBZ) in the 15-month, phase IV, randomized SHORE study (N=202).
From Month (M) 0‒6, patients received 7 monthly RBZ 0.5 mg injections. Between M7 and M14, patients continued to receive monthly RBZ injections until the first month at which pre-specified VA and SD-OCT stability criteria were met. Patients were then randomized 1:1 to continue RBZ monthly or switch to RBZ PRN. Among the patients who met stability criteria during the study, 80% were randomized by M8; 15% of patients were not randomized (ie, discontinued prior to randomization or never met stability criteria through M14), and continued to receive monthly injections throughout the study. Kaplan-Meier analyses were conducted to estimate time to first clinically significant improvement in best-corrected VA (BCVA) defined as gaining of ≥15 letters from BL or achieving Snellen equivalent of 20/40 or better. BL demographics and characteristics were explored as predictors of early VA improvement.
BL factors associated with early improvement to ≥20/40 vision included larger total macular volume (>9.99 mm3), higher BCVA (>50 letters), and presence of subretinal fluid. At M1, 51% of patients achieved ≥20/40 vision. The median time to achieve ≥20/40 vision was 59 days (excluding 22 patients [10.9%] with ≥20/40 vision at M0) and 81% achieved ≥20/40 vision at least one time during the study. At M15, 72% of patients achieved ≥20/40 vision. BL factors associated with an early gain of ≥15-letters included lower BCVA (≤50 letters) and male gender. At M1, 39% of patients gained ≥15 letters from BL. The median time to ≥15-letter gain from BL was 63 days and 85% of all patients gained ≥15 letters at least one time during the study. At M15, 67% of patients gained ≥15 letters.
Rapid improvements in VA to ≥20/40 and gain of ≥15-letters were seen in BRVO and CRVO patients within a median of ~2 months of initiating RBZ therapy. Early improvement to 20/40 was associated with larger total macular volumes, subretinal fluid on BL OCT, and BL BCVA >50 letters. Understanding BL characteristics that are predictive of early VA response to RBZ treatment may be used to guide patients’ and physicians’ expectations at the start of therapy.
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