EFFICACY AND SAFETY OF RANIBIZUMAB FOR THE TREATMENT OF CHOROIDAL NEOVASCULARIZATION DUE TO UNCOMMON CAUSE: Twelve-Month Results of the MINERVA Study. Issue 8 (August 2018)

• Record Type: Journal Article
• Authors: Lai, Timothy Y. Y.; Staurenghi, Giovanni; Lanzetta, Paolo; Holz, Frank G.; Melissa Liew, Shiao Hui; Desset-Brethes, Sabine; Staines, Harry; Hykin, Philip G.
• Is Part Of: Retina. Volume 38:Issue 8(2018)
• Publication Date: 2018-08
• Subjects: anti–vascular endothelial growth factor -- choroidal neovascularization -- choroidal neovascularization etiologies -- angioid streak -- uveitis -- central serous chorioretinopathy -- idiopathic -- phase III -- ranibizumab -- randomized; Retina -- Diseases -- Periodicals; Retinal Diseases; Vitreous Body; 617.735
• DOI: 10.1097/IAE.0000000000001744
• Languages: English
• ISSNs: 0275-004X

Abstract

Abstract : Purpose: 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. Methods: 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). Results: 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. Conclusion: 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. Abstract : Supplemental Digital Content is Available in the Text.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.