June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
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
Author Affiliations & Notes
  • Mohamed Mahgoub
    Ophthalmology, Ain Shams University, Cairo, Egypt
  • Naresh Yadav
    Narayana Nethralaya, Bangalore, India
  • Viktoria Mester
    Ophthalmology, Samaya Specialized Center, Abu Dhabi, Saudi Arabia
  • Kgaogelo Legodi
    Ophthalmology, Medforum Medi-clinic, Pretoria, South Africa
  • Hakyoung Kim
    Ophthalmology, Kangnam Sacred Heart Hospital, Hallym University, Seoul, Republic of Korea
  • Eddy Wu
    Novartis Pharma AG, Basel, Switzerland
  • Sashka Hristoskova
    Novartis Pharma AG, Basel, Switzerland
  • Shelley DiTommaso
    Novartis Pharma AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships Mohamed Mahgoub, Novartis (R); Naresh Yadav, None; Viktoria Mester, NOVARTIS (R); Kgaogelo Legodi, None; Hakyoung Kim, None; Eddy Wu, Novartis Pharma AG (E); Sashka Hristoskova, Novartis Pharma AG (E); Shelley DiTommaso, Novartis Pharma AG (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 6306. doi:
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      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.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: 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

Methods: 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

Results: 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%)

Conclusions: 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

Keywords: 412 age-related macular degeneration • 754 visual acuity  
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