Short-term efficacy and safety of ranibizumab for neovascular age-related macular degeneration in the real world using the regulatory post-marketing surveillance study in South Korea

Session Details

Session Title: Free Paper Session 22: AMD V

Session Date/Time: Sunday 10/09/2017 | 08:00-09:30

Paper Time: 08:24

Venue: Room 115

First Author: : G.Cho SOUTH KOREA

Co Author(s): :    J. Cho   S. Woo                          

Abstract Details

Purpose:

The aim of this study was to investigate the short-term efficacy and safety of ranibizumab in large number of patients with neovascular age-related macular degeneration (nAMD) in the routine clinical setting. This study also aims to analyze the associated factors for visual outcome focusing on the experience of previous treatment.

Setting:

This was post-hoc analysis of ranibizumab regulatory post marketing surveillance (PMS) study in Korea. PMS study was a multi-centre, open-label, 12-week, prospective and observational study with the aim to evaluate the efficacy and safety of ranibizumab under the real clinical practice setting.

Methods:

Ranibizumab PMS study was conducted from July 27, 2007 to July 26, 2013 in Korea. In this post-hoc analysis, 2938 nAMD patients who were treated with three monthly ranibizumab injections were included for safety analysis set and 2811 patients were included in efficacy analysis set after excluding 127 patients who lacked BCVA data. Among the patients in efficacy analysis set, 2167 patients were naïve and 644 patients had prior history of nAMD treatment. Best-corrected visual acuity (BCVA) measurement and funduscopic evaluation were conducted at every visit. Fundus photography, fluorescein angiography and optical coherence tomography were conducted at baseline and week 12. Change of logarithm of the minimum angle of resolution (logMAR) visual acuity, retinal or subretinal haemhorrage, size of choroidal neovascularization (CNV) and exudate were analyzed for efficacy endpoints. Patients were further divided according to the baseline characteristics including, prior treatment history, age, baseline visual acuity and type of CNV. Associations of visual outcome and baseline characteristics were investigated by univariate and multivariate regression analysis. For safety outcome, ocular and systemic adverse events were reported.

Results:

Mean BCVA improved significantly from 0.86±0.57 to 0.73±0.57 after three monthly ranibizumab injections (P<0.001). The change of BCVA was greater in naïve patients compared to non-naïve patients (-0.15±0.38 vs. -0.08±0.35, P<0.001). Size of CNV was decreased (P=0.004) and retinal or subretinal haemhorrage as well as exudate improved at week 12 (P=0.028 and P <0.001). All three anatomical outcomes were more favorable in naïve patients compared to non-naïve patients (P=0.004, P=0.028 and P<0.001). In univariate analysis, patients with no prior treatment, classic type CNV, worse baseline BCVA and younger age showed significantly greater change of visual acuity. In multivariate analysis, no prior treatment history, worse baseline BCVA and younger age were the significant predictive factors for greater improvement of visual acuity. Patients with baseline BCVA <20/320 showed the largest visual improvement (-0.29±0.51) among BCVA groups. There was no new safety signal compared to previous clinical trials.

Conclusions:

In this observational study, conducted in real clinical practice setting with large number of patients, the short-term visual and anatomical outcome improved significantly in patients with nAMD after ranibizuamab treatment. Also, there was no new safety signal compared to clinical trials. Naïve patients showed greater improvement in both functional and anatomical outcomes. No prior treatment history, worse baseline visual acuity and younger age were the predictive factors for greater BCVA change after ranibizumab treatment.

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