Session Title: Free Paper Session 19: Vascular Diseases & Diabetic Retinopathy V
Session Date/Time: Saturday 09/09/2017 | 16:30-18:00
Paper Time: 16:42
Venue: Room 120
First Author: : Y.Chen CHINA
Co Author(s): : J. Zhang J. Ye Q. Han P. Zhao Z. Wu A. Foo
Choroidal neovascularization (CNV) secondary to pathological myopia (myopic CNV) is a major cause of vision loss in adults of working age. Ranibizumab has been approved in many countries for the treatment of CNV secondary to pathologic myopia based on the results from the phase III RADIANCE study. The BRILLIANCE study evaluated the efficacy and safety of two dosing regimens of ranibizumab 0.5 mg versus verteporfin photodynamic therapy (vPDT) in Asian patients with visual impairment due to myopic CNV over 12 months.
BRILLIANCE was a 12-month, phase III, randomised, double-masked, active-controlled study.
Eligible adult patients (≥18 years; N=457) were randomised 2:2:1 into Group 1 (n=182; ranibizumab on day 1, Month 1 and thereafter as needed, guided by visual acuity [VA] stabilisation); Group 2 (n=184; ranibizumab on day 1 and thereafter as needed, guided by disease activity); or Group 3 (n=91; vPDT on day 1; thereafter, from month 3 onwards ranibizumab or vPDT or both as needed, guided by disease activity). The primary study objective was assessment of superiority of both ranibizumab treatments versus vPDT with respect to mean average change in best-corrected VA (BCVA) from baseline to Month 1 through Month 3. The key secondary objective was to demonstrate non-inferiority of Group 2 versus Group 1 with respect to mean average change in BCVA from baseline to Month 1 through Month 6. Other secondary endpoints were mean change in BCVA from baseline to Month 12, ranibizumab treatment exposure and safety over 12 months.
Of the 457 patients, 431 (94.3%) completed the study. At baseline, the mean age of the patients was 51.2 years; majority were female (68.1%) and the mean VA was 53.5 letters. The primary endpoint was met; both the ranibizumab groups showed statistically superior efficacy compared with vPDT (Group 1: +9.5 letters, Group 2: +9.8 letters vs Group 3: +4.5 letters; p<0.001) based on the mean average change in BCVA from baseline to Month 1 through Month 3. The key secondary endpoint was met; ranibizumab treatment guided by disease activity was statistically non-inferior to ranibizumab treatment guided by VA stabilisation with respect to mean average change in BCVA from baseline to Month 1 through Month 6 (10.7 vs 10.4 letters; p<0.001). At Month 12, the mean change in BCVA was 12.0 letters in Group 1, 13.1 letters in Group 2 and 10.3 letters in Group 3. Groups 1, 2 and 3 received a mean of 4.6, 3.9 and 2.6 ranibizumab injections, respectively. No deaths were reported in the study and the rates of adverse events were comparable among treatment groups.
In Asian patients with visual impairment due to mCNV, both ranibizumab treatment regimens, guided by either disease activity or stabilization criteria, demonstrated statistically significant superior efficacy compared with vPDT with respect to mean average change in BCVA from baseline to Month 1 through Month 3. Ranibizumab treatment guided by disease activity was statistically non-inferior to VA stabilization guided treatment with respect to mean average change in BCVA from baseline to Month 1 through Month 6 with a pre-specified non-inferiority margin of −5 letters. The mean BCVA gains at Months 3 and 6 were generally well maintained until Month 12. Overall, ranibizumab was well tolerated with no new safety findings compared to the well-established safety profile of ranibizumab in patients with visual impairment due to myopic CNV.