Purchase this article with an account.
Mohamed Mahgoub, Naresh Yadav, Viktoria Mester, Kgaogelo Legodi, Hakyoung Kim, Eddy Wu, Sashka Hristoskova, Shelley DiTommaso; The UNVEIL (Utilizing raNibizumab intraVitrEal Injection in reaL-world setting) study interim results: Effectiveness and safety of ranibizumab in the treatment of neovascular age-related macular degeneration under real-life conditions in patients from Africa, Asia and the Middle East. Invest. Ophthalmol. Vis. Sci. 2013;54(15):6306.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
A 12-month, multicenter, open label, single cohort, prospective observational study evaluating the effectiveness and safety of ranibizumab in the treatment of neovascular age-related macular degeneration (nAMD) in a diverse population from Africa, Asia and the Middle East under real-life conditions. The study was initiated in September 2010 and will complete in March 2013
Patients with nAMD received ranibizumab 0.5 mg injections in accordance with the prescribing information in participating countries. Treatment decisions, follow-up visits and assessments were at the physician’s discretion. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline (BSL) to Month 3. Secondary endpoints included the proportion of patients with ≥15 letters of VA gain, mean change in central retinal thickness (CRT) from BSL to Months 3 and 12, and safety. The 3-month related objectives and safety were included in the interim analysis
385 patients were evaluated in the analysis. The majority of patients were Asians (88.1%) including 246 (63.9%) patients from India and 90 (23.4%) from South Korea. 61% of patients were males. The mean age was 66.8 years. The mean duration of nAMD was 0.6 years. 314 (81%) patients were nAMD treatment naïve. At BSL, the mean BCVA and CRT were 70.2 (17.4 standard deviation [SD]) letters and 354.7 (144.7 SD) µm, respectively. At Month 3, the mean gain in BCVA was 7.7 (13.9 SD) letters and mean reduction in CRT was 97.7 (145.0 SD) µm, both were statistically significant compared to BSL (p<0.001). The proportion of patients with ≥15 letters gain was 33.6%. Most commonly observed adverse events were vitreous floaters (4 patients, 1%), transient vision blurred (3, 0.8%), and upper respiratory tract infection (2, 0.5%)
The interim analysis results showed that ranibizumab treatment resulted in significant vision gain and CRT reduction at Month 3 and was well tolerated under real-life conditions in a diverse group of nAMD patients from Africa, Asia and the Middle East. The findings are in accordance with the efficacy and safety profile of ranibizumab observed in controlled randomized clinical trials
This PDF is available to Subscribers Only