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Francesco Bandello; Twelve-month efficacy and safety of ranibizumab 0.5 mg(RBZ) versus verteporfin photodynamic therapy(vPDT) in the treatment of visual impairment(VI) due to choroidal neovascularization(CNV) secondary to pathologic myopia(PM). Invest. Ophthalmol. Vis. Sci. 2013;54(15):1247.
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© ARVO (1962-2015); The Authors (2016-present)
PM is the leading cause of CNV causing visual impairment in individuals ≤50 years. This is the first randomized controlled study reporting the 12 month(M) efficacy and safety of two different dosing regimens of RBZ vs vPDT in the treatment of VI due to CNV secondary to PM.
A 12M, phase III, multicenter, double-masked, active controlled study. Patients(n=277) were randomized 2:2:1 to Group(G)1(G1, n=106) with RBZ treatment on Day1, M1, individualized treatment as needed(pro re nata[PRN]) as of M2 based on visual acuity(VA) stability, G2(n=116) with RBZ treatment on Day1, PRN as of M1 based on disease activity, and G3(n=55) with vPDT on Day1 and thereafter at investigator discretion(minimum quarterly interval) with RBZ as of M3. Primary endpoint: RBZ superiority to vPDT based on mean average best-corrected visual acuity(BCVA) change from baseline(BSL) to M1-3. Secondary endpoints: non-inferiority of G2 vs G1 based on mean average BCVA change from BSL to M1-6(key), mean change in BCVA from BSL to M12, patients gaining ≥10 letters, and safety over 12M.
267(96.4%) patients completed 12M. BSL characteristics: mean age(years) 54(G1), 56.1(G2), 57.4(G3); females(75.5%); and mean VA 55.4(G1), 55.8(G2), and 54.7(G3). Both RBZ groups were superior to vPDT in improving mean average BCVA change from BSL to M1-3 (+10.5[G1], +10.6[G2] vs +2.2 letters[G3; both p<0.00001], primary endpoint met). G2 was non-inferior to G1 based on mean average BCVA change from BSL to M1-6(+11.7[G2] vs +11.9[G1] letters; p<0.00001). Mean BCVA change at M12: +13.8(G1), +14.4(G2), +9.3(G3, after M3 with RBZ) letters. At M12: 69.5%(G1), 69.0%(G2), and 49.1%(G3, after M3 with RBZ) of patients gained ≥10 letters. Mean RBZ injections(Day1-M11): 4.6(G1), and 3.5(G2). No reports of endophthalmitis, deaths; no new ocular/nonocular safety findings with RBZ over 12M.
RBZ treatment based on VA stability or disease activity criteria demonstrated superior BCVA gain vs vPDT at M3. Mean RBZ injections over 12M: 4.6(G1) and 3.5(G2). No new safety findings were identified in patients with VI due to CNV secondary to PM.
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