To evaluate the efficacy and safety of ranibizumab 0.5 mg in adult patients with choroidal neovascularization because of an uncommon cause enrolled in the 12-month MINERVA study.
In this Phase III, double-masked study, adult (≥18 years) patients (N = 178) were randomized 2:1 to receive either ranibizumab (n = 119) or sham (n = 59) at baseline and, if needed, at Month 1 and open-label individualized ranibizumab from Month 2. Best-corrected visual acuity change from baseline to Month 2 (primary endpoint) and Month 12, treatment exposure, and safety over 12 months were reported. Subgroup analysis was conducted on five predefined choroidal neovascularization etiologies (angioid streak, postinflammatory, central serous chorioretinopathy, idiopathic, and miscellaneous).
Ranibizumab showed superior efficacy versus sham from baseline to Month 2 (adjusted least-squares mean best-corrected visual acuity: +9.5 vs. −0.4 letters; P < 0.001). At Month 12, the mean best-corrected visual acuity change was +11.0 letters (ranibizumab) and +9.3 letters (sham). Across the 5 subgroups, the treatment effect ranged from +5.0 to +14.6 letters. The mean number of ranibizumab injections was 5.8 (ranibizumab arm) with no new ocular or nonocular adverse events.
Ranibizumab 0.5 mg resulted in clinically significant treatment effect versus sham at Month 2. Overall, ranibizumab was effective in treating choroidal neovascularization of various etiologies with no new safety findings.
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Ranibizumab was effective in treating choroidal neovascularization of various etiologies, with a treatment effect of +9.9 letters versus sham at Month 2 and a mean gain of 11.0 letters from baseline to Month 12. The beneficial effects of ranibizumab were observed across all etiology subgroups.
*Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Eye Hospital, Kowloon, Hong Kong, SAR;
†Department of Biomedical and Clinical Science Luigi Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy;
‡Department of Medical and Biological Sciences Ophthalmology, University of Udine, Udine, Italy;
§Istituto Europeo di Microchirurgia Oculare (IEMO), Udine, Italy;
¶Department of Ophthalmology, University of Bonn, Bonn, Germany;
**Novartis Pharmaceuticals Corporation, East Hanover, New Jersey;
††Novartis Pharma AG, Basel, Switzerland;
‡‡Sigma Statistical Services, Balmullo, St Andrews, Scotland, United Kingdom; and
§§NIHR Biomedical Centre for Research in Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.
Reprint requests: Timothy Y. Y. Lai, MD, FRCOphth, Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 3/F Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong, SAR; e-mail: email@example.com
This multicenter study was funded and managed by Novartis Pharma AG and is registered with www.clinicaltrialsregister.eu (EudraCT no. 2012-005417-38).
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