To evaluate long-term efficacy and safety of ranibizumab for treatment of myopic choroidal neovascularization (mCNV) in clinical practice.
Noninterventional, retrospective cohort study of East-Asian patients previously treated with ranibizumab during the RADIANCE trial. Forty-one patients who completed the RADIANCE trial were followed-up for up to 48 months (post-RADIANCE observation period). Outcome measures were best-corrected visual acuity changes from baseline (assessed at RADIANCE trial initiation), mCNV recurrences, and ocular adverse events.
Mean visual gain from baseline best-corrected visual acuity (56.5 ± 12.1 letters) (20/80) was significant at 12 months (+14.3 ± 11.4 letters, n = 40, P < 0.0001), 24 months (+10.4 ± 22.3 letters, n = 31, P = 0.0143), 30 months (+11.0 ± 22.4 letters, n = 29, P = 0.0134), 42 months (+12.9 ± 20.9 letters, n = 25, P = 0.0051), and 48 months (+16.3 ± 18.7, n = 16, P = 0.0034). Of the 16 patients who completed 48 months of follow-up, 63% gained ≥10 letters and 13% lost ≥10 letters. Over the post-RADIANCE observation period, 83% of patients required no further treatment for mCNV, 10% experienced mCNV recurrences, and 12% experienced a nonserious ocular adverse event. Patients who required additional treatment for mCNV received a mean of 5.0 (SD 5.9, range 1.0–18.0) ranibizumab injections.
Best-corrected visual acuity gained at the end of the RADIANCE trial was sustained over additional 36 months of follow-up. Few patients required further treatment and no new safety concerns were observed.
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A retrospective cohort study of East-Asian patients previously treated with ranibizumab for myopic choroidal neovascularization in the RADIANCE trial. Clinical charts were reviewed to assess long-term efficacy and safety. Visual acuity was sustained for additional 36 months after trial completion with few patients requiring additional treatment and no new safety concerns observed.
*Eye Surgeons@ Novena, Mount Elizabeth Novena Specialist Centre, Singapore, Singapore;
†Tokyo Medical and Dental University, Bunkyo-ku, Japan;
‡Department of Ophthalmology, The Institute of Vision Research, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea;
§Department of Ophthalmology, Kansai Medical University, Hirakata, Japan;
¶RWE, IMS Health Spain, Barcelona, Spain;
**Novartis Pharma AG, Basel, Switzerland; and
††Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Eye Hospital, Kowloon, Hong Kong.
Reprint requests: Montse Pedros, MD, C/Provença 392, 3rd floor, 08025 Barcelona, Spain; e-mail: Montserrat.Pedros@quintilesims.com
This study was funded by Novartis Pharma AG, Basel, Switzerland.
N. W. Tan received honoraria as a consultant from Bayer HealthCare and Novartis Pharma AG and lecture fees from Allergan, Bayer HealthCare, and Novartis Pharma AG. K. Ohno-Matsui received research funds from Novartis. H. J. Koh received lecture fees (honoraria) from Novartis Pharma AG and Bayer HealthCare. Y. Nagai received lecture fees (honoraria) from Novartis Pharma AG, Bayer HealthCare, and Santen Pharma Ltd. M. Pedros works as a consultant at IMS Health at the time of the study, which received funding from Novartis Pharma AG. R. L. Freitas worked as a consultant at Wellmera AG at the time of the study, which received funding from Novartis Pharma AG. W. Macfadden is a full time employee at Novartis Pharma AG. T. Y Lai received honoraria as a consultant from Allergan, Bayer, Genentech, and Novartis Pharma AG and lecture fees from Allergan, Bayer, and Novartis Pharma AG.
Under direction of the authors, Heidi Eriksen (GSM Safety Ltd) drafted the initial version of the manuscript. IMS Health provided overall study management, performed statistical analyses and verified accuracy of the data presented.