Ranibizumab Use in Patients with CNV Secondary to Pathologic Myopia
In the following Phase III, 12-month, randomized, double-masked, multicenter, active-controlled study, investigators compared the efficacy and safety of ranibizumab 0.5 mg, guided by visual acuity (VA) stabilization or disease activity criteria, versus verteporfin photodynamic therapy (vPDT) in patients with visual impairment due to myopic choroidal neovascularization (CNV).
The study included 277 patients with visual impairment due to myopic CNV and the investigators randomized patients to receive ranibizumab on day one, month one and thereafter as needed guided by VA stabilization criteria (group one, n=106); ranibizumab on day one and thereafter as needed guided by disease activity criteria (group two, n=116); or vPDT on day one and disease activity treated with ranibizumab or vPDT at investigators' discretion from month three (group three, n=55). The main outcome measure was mean average best-corrected visual acuity (BCVA) change from baseline to month one through months three (primary) and six, mean BCVA change and safety over 12 months.
According to the investigators, ranibizumab treatment in groups one and two was superior to vPDT based on mean average BCVA change from baseline to month one through month three (group one: +10.5, group two: +10.6 vs. group three: +2.2 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; both p<0.0001). They also observed that ranibizumab treatment guided by disease activity was noninferior to VA stabilization-guided retreatment based on mean average BCVA change from baseline to month one through month six (group two: +11.7 vs. group one: +11.9 ETDRS letters; p<0.00001). Mean BCVA change from baseline to month 12 was +13.8 (group one), +14.4 (group two) and +9.3 ETDRS letters (group three). At month 12, 63.8% to 65.7% of patients showed resolution of myopic CNV leakage. Patients received a median of 4.0 (group one) and 2.0 (groups two and three) ranibizumab injections over 12 months. No deaths or cases of endophthalmitis and myocardial infarction occurred.
Ranibizumab treatment, irrespective of retreatment criteria, provided superior BCVA gains versus vPDT up to month three, the investigators found. Ranibizumab treatment guided by disease activity criteria was noninferior to VA stabilization criteria up to month six. Over 12 months, individualized ranibizumab treatment was effective in improving and sustaining BCVA and was generally well-tolerated in patients with myopic CNV.