Short-term Efficacy and Safety of Ranibizumab for Neovascular Age-related Macular Degeneration in the Real World: A Post-marketing Surveillance Study
- Author:
Se Joon WOO
1
;
Ga Eun CHO
;
Joon Hee CHO
Author Information
- Publication Type:Original Article
- Keywords: Efficacy; Age-related macular degeneration; Post marketing surveillance; Ranibizumab; Real-world evidence
- MeSH: Choroidal Neovascularization; Exudates and Transudates; Hemorrhage; Humans; Macular Degeneration; Ranibizumab; Visual Acuity
- From:Korean Journal of Ophthalmology 2019;33(2):150-166
- CountryRepublic of Korea
- Language:English
- Abstract: PURPOSE: To investigate the short-term efficacy and safety of ranibizumab in the routine clinical setting in patients with neovascular age-related macular degeneration and to analyze the associated factors for visual outcome. METHODS: This was a post-hoc analysis of a ranibizumab regulatory post-marketing surveillance study in which 4,136 patients were enrolled and followed for 12 weeks. Change in best-corrected visual acuity (BCVA), size of choroidal neovascularization, and the presence of hemorrhage and exudate were analyzed and the association between BCVA change and baseline characteristics were investigated. Data on ocular and systemic adverse events were collected. RESULTS: Mean BCVA improved significantly and mean BCVA change was the logarithm of the minimal angle of resolution 0.13 ± 0.01 (p < 0.001). A lower baseline BCVA and younger age were significant predictive factors for visual improvement or maintenance (≥0 lines). For greater visual acuity gain (≥3 lines), no treatment history, lower baseline BCVA, younger age, and classic-type choroidal neovascularization were significant predictive factors. No new safety signals were found. CONCLUSIONS: In this study, conducted in real-world clinical practice with a large number of neovascular age-related macular degeneration patients, visual and anatomical outcomes improved significantly after three monthly ranibizumab treatments. Treatment-naive patients had a higher chance of greater visual gain (≥3 lines) than non-naive patients.
