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Eric H Souied, Boris Gekkiev, Adrien Bretagne, Stefan Pilz, Sue Lacey, LUMINOUS; Ranibizumab in a real-world clinical setting: 2014 interim analysis of the 5-year observational multicenter LUMINOUS study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1417.
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© ARVO (1962-2015); The Authors (2016-present)
LUMINOUS (NCT01318941, initiated March 2011) is the largest prospective observational global study in the field of medical retina. The study is designed to evaluate the long-term safety, effectiveness, treatment patterns, and health-related quality-of-life associated with ranibizumab 0.5 mg treatment, across all approved indications, in 30,000 patients from routine clinical practice. We present data from the 2014 interim analysis.
This interim analysis included 3 cohorts: Cohort 1, baseline characteristics of patients enrolled before March 2014 (N=20,085; nAMD, n=17,546; DME, n=1,758; BRVO, n=393; CRVO, n=350); Cohort 2, patients with potential for 1-year follow-up enrolled before March 2013 (N=9790; nAMD, n=9125; DME, n=427; BRVO, n=119; CRVO, n=119); and Cohort 3, patients with potential for 2-year follow-up enrolled before March 2012 (nAMD, N=2001).
Cohort 1: LUMINOUS included patients with diverse demographics and baseline characteristics (Table 1). Across all indications, mean baseline visual acuity (VA, ETDRS letters) was higher in patients previously treated with ranibizumab (56.5) than in treatment-naïve patients (49.3). Cohort 2: The 1-year data showed that on average treatment-naïve patients gained VA from baseline whilst those previously treated with ranibizumab either gained or maintained VA. These outcomes were obtained with a relatively low number of injections and visits (Table 2). In nAMD, VA was maintained at 1-year even in those patients who were previously treated with ranibizumab for ≥6 years. Cohort 3: At Year 2, there was a mean increase in VA of 2.0 ETDRS letters from a baseline VA of 54.9 ETDRS letters in treatment naïve patients whilst those previously treated with ranibizumab lost 3.0 ETDRS letters of VA from a higher baseline of 60.4 ETDRS letters. At Year 1 (Cohort 2) and Year 2 (Cohort 3), the rates of ocular and non-ocular serious adverse events were 0.54/0.70% and 6.52/13.34%, respectively.
This interim analysis of LUMINOUS study data reinforces the well-established efficacy and safety profile of ranibizumab in a real-world clinical setting. LUMINOUS will provide an invaluable source of long-term real-world data.
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