Abstract
Purpose:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
Keywords: 412 age-related macular degeneration •
466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials •
748 vascular endothelial growth factor