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Sanjay Sharma, Soumil Parikh, Wayne Macfadden; Ranibizumab treatment for nAMD in clinical practice: outcomes from the LUMINOUS™ study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):837. doi: https://doi.org/.
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Ranibizumab has a well-established efficacy and safety profile for the treatment of neovascular age-related macular degeneration (nAMD) based on several randomized controlled trials (RCTs); its effectiveness has also been demonstrated in real-world practice. LUMINOUS (NCT01318941) 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 1-and 2-year outcomes of ranibizumab treatment in treatment-naïve nAMD patients 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 nAMD cohort.
The LUMINOUS study enrolled 6,241 treatment-naïve nAMD patients. At baseline, their mean (SD) age was 75.0 (10.2) years, 54.9% were female, and 66.5% were Caucasian. Baseline and 1-year VA data are available for 3,379 patients and for this cohort, the mean (SD) VA improved by 3.1 (16.5) letters at 1 year from a baseline of 51.9 (21.0) letters with a mean (SD) of 5.0 (2.7) ranibizumab injections and 8.8 (3.3) monitoring visits. VA gains were greater in patients receiving ≥3 ranibizumab injections in Year 1 (Figure 1). Similar to Year 1, VA gains at Year 2 were greater in patients (n=2,024) with lower baseline VA (Figure 2). Across all treatment-naïve nAMD patients (N=6,241), the incidence of ocular/non-ocular AEs and SAEs was 8.2%/12.8% and 0.9%/7.4%, respectively.
LUMINOUS confirms the effectiveness of ranibizumab in treatment-naïve nAMD patients, particularly in those receiving a higher number of ranibizumab injections; baseline vision was an important predictor for VA outcomes. No new safety signals were identified with ranibizumab treatment.
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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