Abstract
Purpose :
To assess the efficacy and safety of an individualized dosing regimen of ranibizumab 0.5 mg in Asian (primarily Chinese) patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).
Methods :
A 12-month, phase III, multicenter, double-masked, randomized, sham-controlled study. Patients with CRVO were randomized 3:1 to receive ranibizumab pro re nata (PRN) or sham. Ranibizumab-group patients received 3 initial consecutive monthly injections, followed by individualized stabilization criteria-driven PRN treatment. Sham-group patients received sham injections up to Month 2 and could receive ranibizumab PRN from Month 3 onwards. The primary objective was to demonstrate superiority of ranibizumab versus sham based on the average best-corrected visual acuity (BCVA) change from baseline to Month 1 through Month 3. Secondary endpoints included change in BCVA and central subfield thickness (CSFT) over time, treatment exposure, and safety over 12 months.
Results :
Of the 252 patients (ranibizumab, n=190 and sham, n=62), 89.7% patients completed the study; majority (82.5%) were of Chinese ethnicity. The mean age was 54.1 years; 53.6% patients were male. Mean baseline BCVA was 53.2 and 53.6 letters in the ranibizumab and sham groups, respectively. Ranibizumab was superior to sham at Month 3 (least squares mean average change in BCVA from baseline: +11.3 vs -2.7 letters, one-sided p<0.001 [derived from Cochran-Mantel-Haenszel test]). At month 12, the mean change in BCVA (Figure 1) and CSFT (Figure 2) from baseline was +14.5 letters and -441.7 μm in ranibizumab group and +6.5 letters and -416.4 μm in the sham group, respectively. Over 12 months, the mean number of ranibizumab injections were 8.2 and 6.2 in the ranibizumab and sham groups, respectively. No new safety signals were reported over 12 months.
Conclusions :
In Asian patients, individualized stabilization criteria-driven PRN ranibizumab was superior to sham with regards to early VA gains that were maintained throughout study. Despite switching to ranibizumab from Month 3, the BCVA gains in the sham group never reached the same level as in the ranibizumab group at month 12, showing the benefit of early treatment in achieving optimal visual outcomes. The safety profile of ranibizumab was consistent with that reported previously.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.