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Ian A Pearce, Ayan Das Gupta, Sue Lacey, LUMINOUS; One-year outcomes of ranibizumab treatment in a cohort of patients with retinal vein occlusion: an interim analysis from the real-world LUMINOUS study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3743.
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© ARVO (1962-2015); The Authors (2016-present)
Ranibizumab is approved for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion [RVO; branch (BRVO) or central (CRVO)] in many countries worldwide. However, there are limited data on its use in RVO patients in a real-world setting. We present the preliminary baseline characteristics of RVO patients enrolled before March 2014 and 1-year results of RVO patients enrolled into the LUMINOUS study before March 2013.
LUMINOUS (NCT01318941) is an ongoing 5-year, global, multicenter, prospective, observational study designed to evaluate the long-term safety, effectiveness, treatment patterns and health-related quality-of-life outcomes associated with ranibizumab 0.5 mg treatment in clinical practice. Consenting adult RVO patients, treatment naïve or those previously treated with ranibizumab/other ocular treatments, were treated according to the local product label.
At baseline BRVO/CRVO patients (N=393/350) had a mean age of 69.0/68.2 years, 54.2/44.0% were female, and 82.7/84.3% were Caucasian. The baseline mean visual acuity (VA, ETDRS letters, primary treated eye) for BRVO/CRVO was 52.0/43.1 in treatment naïve patients and 58.2/49.8 in patients previously treated with ranibizumab. One-year follow-up data were available for 119 patients each for BRVO/CRVO. The patients who completed 1 year (BRVO/CRVO) showed mean VA (letters) gains of 7.0/13.2 (n=7/15) in treatment naïve patients and 8.0/1.4 (n=20/16) in those previously treated with ranibizumab (Figure). The VA gains were observed with a relatively low mean number of injections and monitoring visits (BRVO/CRVO: treatment naïve, 3.6/3.8 injections and 5.8/5.3 monitoring visits; previously treated with ranibizumab, 3.7/3.3 injections and 6.2/5.8 monitoring visits). The rates of ocular and non-ocular serious adverse events were 1.3% and 3.8%, respectively (Table).
At one year, ranibizumab 0.5 mg treatment led to improvement or maintenance of VA outcomes in RVO patients irrespective of pre-treatment status, with a low mean number of injections and monitoring visits. Outcomes from this interim analysis of the LUMINOUS study reinforce the well-established safety and efficacy profile of ranibizumab in RVO.
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