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Ian Pearce, Soumil Parikh, Wayne Macfadden; Real-world outcomes of ranibizumab in patients with retinal vein occlusion from the LUMINOUS™ study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):2566.
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LUMINOUS (NCT01318941), the largest prospective observational study in retinal medicine, evaluated the long-term effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in clinical practice across all approved indications. Here, we present the effectiveness and safety of ranibizumab treatment in patients with retinal vein occlusion (RVO; branch RVO [BRVO] or central RVO [CRVO]) from the final analysis of the LUMINOUS study.
LUMINOUS (initiated in March 2011) is a recently completed, 5-year, prospective, multicenter, non-interventional, open-label study that enrolled more than 30,000 patients from 488 sites across 42 countries. Consenting adult (≥18 years) patients who were treatment-naïve or previously treated with ranibizumab or other ocular treatments were enrolled and treated with ranibizumab for the approved indication according to the local product label. Data were analyzed by indication and by prior treatment status of the study eye. Reported here are the 1-and 2-year visual acuity (VA; primary treated eye) outcomes, injection patterns, adverse events (AEs) and serious AEs (SAEs) for the treatment-naïve RVO cohort.
Of the 732 treatment-naïve RVO patients recruited worldwide, 405 had BRVO and 327 had CRVO. At baseline, the mean age of treatment-naïve BRVO/CRVO patients was 67.9/68.9 years, 42.5%/56.9% were male, and 71.9%/76.8% were Caucasian. At 1 year, there was an average mean VA improvement of greater than 10 letters in both treatment-naïve BRVO (n=189) and CRVO (n=144) patients (Figure 1). VA gains were higher in RVO patients who received at least two ranibizumab injections (Figure 1). Similar to Year 1, VA gains at Year 2 were greater in RVO patients (BRVO, n=67; CRVO, n=48) with lower baseline VA (Figure 2). The rate of ocular/non-ocular AEs and SAEs was 7.4%/9.1% and 0.3%/4.4% across all treatment-naïve BRVO patients (N=405) and 11.3%/8.6% and 1.2%/6.7% in CRVO patients (N=327), respectively.
Ranibizumab treatment for 1 year resulted in improved VA in treatment-naïve patients with RVO and this improvement was greater with increased injection frequency. No new safety signals were identified with ranibizumab treatment. These results from LUMINOUS demonstrate the effectiveness and safety of ranibizumab for the treatment of RVO in real-world clinical practice.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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