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Tien Y Wong, Tatsuro Ishibashi, Kyoko Ohno-Matsui, Yasushi Ikuno, Jean-Francois Korobelnik, Brigitte Stemper, Yoshimi Matsuda, Tummy Li, Robert Vitti, Oliver Zeitz, ; Efficacy and Safety of Intravitreal Aflibercept for Choroidal Neovascularization Secondary to Pathological Myopia: 48-week Results of MYRROR Study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):4960.
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To evaluate the efficacy and safety of intravitreal aflibercept for treatment of choroidal neovascularization (CNV) secondary to pathological myopia.
MYRROR is a 48-week, Phase 3, multicenter, randomized, double-masked, sham-controlled study in which patients with myopic CNV were randomized 3:1 to aflibercept 2 mg or sham treatment. Patients assigned aflibercept received a single injection at baseline followed by additional injections in case of CNV persistence or recurrence with monthly assessments until Week 44. Confirmatory analyses were performed for “mean change in best-corrected visual acuity” at Week 24 (primary endpoint) and for the “proportion of patients gaining ≥15 letters from baseline” at Week 24 (secondary endpoint). From Week 24, patients receiving sham were switched to aflibercept 2 mg.
122 patients were randomized to aflibercept (n=91) or sham (n=31). Baseline demographics were similar. At Week 24, patients in the aflibercept group gained a mean 12.1 letters compared to a loss of 2 letters in sham (P<0.0001). 38.9% of patients in the aflibercept group vs 9.7% in sham gained ≥15 letters from baseline (P=0.0001). By Week 48, the aflibercept 2-mg group gained a mean 13.5 letters (50% gained ≥15 letters). Patients in the aflibercept 2-mg group received a median of 2 injections (range 1-3) in the 1st quarter of the study. In the 2nd to the 4th quarter the median number of injections was 0 (range 0-3). At Week 48 the sham/aflibercept group gained 3.9 letters from baseline (29% gained ≥15 letters) with a median 2 active injections (range 0-3) in Week 24-32 and 1 (range 0-3) in Week 36-44. The most commonly reported (≥2%) treatment-emergent adverse events (TEAEs) were nasopharyngitis, conjunctival hemorrhage, dry eye, eye pain, and headache. From Week 0-48 the incidence of ocular TEAEs was similar with 37.4% in AFL 2-mg vs 38.7% in the sham/aflibercept 2-mg group. The majority of TEAEs in both groups were mild, with no deaths.
Intravitreal aflibercept was well tolerated and resulted in a clinically meaningful improvement in patients with myopic CNV. Most injections were given in the 1st quarter of the study with minimal reinjections over subsequent quarters, while vision benefits were maintained or extended. Myopic CNV can be successfully managed with short-term intravitreal aflibercept treatment.
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