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Naresh Yadav, Shelley diTommaso, Hakyoung Kim, Kgaogelo Legodi, Mohamed M Mahgoub, Viktoria Mester, Eddy Wu; Real-world observations of ranibizumab treatment for neovascular age-related macular degeneration in patients from Africa, Asia and the Middle East: Final results from the UNVEIL study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3064.
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The UNVEIL study was a multicenter, 12-month, prospective, non-interventional study that evaluated the effectiveness and safety profile of ranibizumab in the treatment of neovascular age-related macular degeneration (nAMD) during real-life clinical practice, in patients from Egypt, India, United Arab Emirates, Lebanon, Kuwait, Philippines, South Africa and South Korea.
Patients were treated with ranibizumab (0.5 mg) for nAMD according to their usual local treatment practices. The primary study endpoint was the mean change in best-corrected visual acuity (BCVA) from baseline to month 3 (ETDRS letters). Secondary endpoints included the mean change in BCVA from baseline to month 12; the mean change in central retinal thickness (CRT) at 3 and 12 months, and the number of adverse events (AEs). Results are reported as the mean ± standard deviation and ‘n’ denotes the number of treated eyes.
A total of 901 nAMD patients (age 67 ± 12.07 years) participated in the study and 505 patients completed the study. BCVA was 62.3 ± 22.59 letters at baseline (n = 842). This increased by 8.0 ± 13.87 (n = 667, p<0.001) and 7.5 ± 16.26 letters (last observation carried forward [LOCF], n = 768, p<0.001) at months 3 and 12, respectively. CRT was 350.5 ± 142.38 µm at baseline (n = 678) and decreased by 97.3 ± 134.98 (n = 444, p<0.001) and 88.6 ± 141.21 µm (LOCF, n = 460, p<0.001) at months 3 and 12, respectively. The mean number of injections per treated eye during the loading phase (months 0-2) and maintenance phase (months 3-12) was 2.3 ± 0.73 (n = 906) and 1.6 ± 1.19 (n = 444), respectively. AEs were reported in 69 patients (7.7%) with 27 patients (3%) reporting ocular-related AEs. Fifteen serious AEs were observed in 12 patients (1.3%). One serious AE, retinal hemorrhage, was suspected to be injection related.
This is the first large-scale, multicenter, real-life study to investigate the effectiveness and safety profile of ranibizumab-treated nAMD patients across these countries. Despite the wide variations in healthcare infrastructures and a relatively lower mean injection number than published observational studies from Western societies, real-life ranibizumab treatment resulted in significant gains in vision, morphological improvements, and a low incidence of AEs.
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