Session Title: Free Paper Session 9: AMD III
Session Date/Time: Friday 08/09/2017 | 08:00-09:30
Paper Time: 08:30
Venue: Room 117
First Author: : S.Chen TAIWAN
Co Author(s): : C. Lai C. Cheng L. Yeung J. Liu J. Chen S. Sheu
Ranibizumab 0.5 mg was approved in 2011 in Taiwan for the treatment of nAMD based on the results from the Phase III ANCHOR and MARINA studies. The effectiveness and safety of ranibizumab in nAMD is established in Caucasian patients through several studies, but in Asian patients data are limited to the EXTEND studies during the study period. Thus, there is a need to optimize the individual treatment regimen in Asian patients treated with ranibizumab. Here we present for the first time the real-world effectiveness and safety data of ranibizumab 0.5 mg in Taiwanese patients with nAMD from the REAL study.
A 12-month, multicentre, open-label, non-interventional, prospective, post-marketing surveillance study conducted across 9 study centres in Taiwan.
Consenting adult (≥18 years) Asian patients with primary or recurrent subfoveal choroidal neovascularisation secondary to nAMD including those with predominantly classic, minimally classic, or active occult lesions with no classic component, best-corrected visual acuity (BCVA) score between 73 and 20 letters, independent of their previous treatment status, were included in the study. Patients with subfoveal fibrosis or atrophy were excluded from the study. Patients were treated with ranibizumab 0.5 mg as per local product label in Taiwan. The primary objective of the study was to observe effectiveness of ranibizumab 0.5 mg treatment based on mean change in BCVA from baseline to Month 3 post treatment initiation with ranibizumab. Secondary outcomes assessed mean change in BCVA from baseline to Months 6 and 12. Safety outcomes were assessed for the 12-month study duration. A subgroup analysis was performed on the proportion of patients gaining <5 letters and mean change in BCVA for patients receiving <3, 3 and >3 ranibizumab injections at Months 3, 6 and 12.
Of the 303 patients with nAMD enrolled, 228 completed the 12-month study. At baseline, the mean age of patients was 72.4 years, 65.6% of patients were male and the mean [BCVA (±standard deviation; SD)] was 50.2 (±13.3) letters. The mean change in BCVA (±SD) from baseline was significant at Months 3 and 6 (4.1 [±11.1] and 3.7[±13.3]; p<0.0001) letters, respectively, and at Month 12 it was 0.4 (±16.9; p=0.6982) letters. The proportion of patients with an increase of ≥5 letters in BCVA was 42.2% at Month 3, 46.4% at Month 6 and 43.2% at Month 12. The mean (±SD) number of ranibizumab injections administered was 3.2 (±1.3) during the 12-month study. The mean change in BCVA (±SD) from baseline to Month 3 was significant in patients receiving <3/3/>3 ranibizumab injections (n=55, 167, 63) was 5.0(±11.8; p=0.0037)/4.5(±11.0; p <0.0001)/2.0(±10.6; p=0.1527) letters. The mean change in BCVA in patients receiving <3/3/>3 injections was 3.7±13.6/4.5±13.7/2.0±12.1 letters at Month 6 and 0.9±15.8/1.0±16.6/−1.0±18.6 at Month 12 respectively. Ocular (study eye) adverse events (AEs) were reported in 10.6% of patients. One patient experienced endophthalmitis and one death that was unrelated to ranibizumab was reported.
The REAL study demonstrated the effectiveness of ranibizumab 0.5 mg with maintenance of visual gains, over the 12-month study duration in a real-world setting, in the Taiwanese patients with nAMD with relatively low number of injections capped by the National Health Insurance Scheme during the study period. Overall, ranibizumab was well tolerated and the safety findings were similar to the well characterized safety profile of ranibizumab in nAMD.