Short-term Efficacy and Safety of Ranibizumab for Neovascular Age-related Macular Degeneration in the Real World: A Post-marketing Surveillance Study
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Purpose: To investigate the short-term efficacy and safety of ranibizumab in the routine clinical setting in patientswith 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 which4,136 patients were enrolled and followed for 12 weeks. Change in best-corrected visual acuity (BCVA), sizeof choroidal neovascularization, and the presence of hemorrhage and exudate were analyzed and the associationbetween BCVA change and baseline characteristics were investigated. Data on ocular and systemicadverse events were collected. Results: Mean BCVA improved significantly and mean BCVA change was the logarithm of the minimal angle ofresolution 0.13 ± 0.01 (p < 0.001). A lower baseline BCVA and younger age were significant predictive factorsfor 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 predictivefactors. No new safety signals were found. Conclusions: In this study, conducted in real-world clinical practice with a large number of neovascular age-relatedmacular degeneration patients, visual and anatomical outcomes improved significantly after three monthlyranibizumab treatments. Treatment-naive patients had a higher chance of greater visual gain (≥3 lines) thannon-naive patients.
Abstract
Purpose: To investigate the short-term efficacy and safety of ranibizumab in the routine clinical setting in patientswith 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 which4,136 patients were enrolled and followed for 12 weeks. Change in best-corrected visual acuity (BCVA), sizeof choroidal neovascularization, and the presence of hemorrhage and exudate were analyzed and the associationbetween BCVA change and baseline characteristics were investigated. Data on ocular and systemicadverse events were collected. Results: Mean BCVA improved significantly and mean BCVA change was the logarithm of the minimal angle ofresolution 0.13 ± 0.01 (p < 0.001). A lower baseline BCVA and younger age were significant predictive factorsfor 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 predictivefactors. No new safety signals were found. Conclusions: In this study, conducted in real-world clinical practice with a large number of neovascular age-relatedmacular degeneration patients, visual and anatomical outcomes improved significantly after three monthlyranibizumab treatments. Treatment-naive patients had a higher chance of greater visual gain (≥3 lines) thannon-naive patients.
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