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Ranibizumab in patients with neovascular age‐related macular degeneration: results from the real‐world LUMINOUS ™ study
Author(s) -
Souied E.,
Clemens A.,
Macfadden W.
Publication year - 2017
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2017.01111
Subject(s) - ranibizumab , medicine , macular degeneration , ophthalmology , visual acuity , incidence (geometry) , adverse effect , choroidal neovascularization , cohort , surgery , bevacizumab , chemotherapy , physics , optics
Purpose LUMINOUS ( NCT 01318941) was designed to evaluate the long‐term safety, effectiveness, and treatment patterns with ranibizumab 0.5 mg in clinical practice across all licensed indications. We report, the effectiveness and safety of ranibizumab treatment in patients with neovascular age‐related macular degeneration ( nAMD ) from the final analysis of LUMINOUS . Methods LUMINOUS is a recently‐completed, 5‐year, global, observational study. Consenting adult patients were treated as per the local ranibizumab label. Reported are the 1‐year visual acuity ( VA , primary treated eye), and injection pattern for the treatment‐naïve nAMD patients. The incidence of adverse events ( AE s) and serious AE s ( SAE s) for the total treatment‐naïve nAMD cohort is also presented. Results Baseline and 1‐year VA data were available for 2701 treatment‐naïve nAMD patients. At baseline, the mean ( SD ) age was 75.9 (9.7) years, 58.4% were female, and 78.4% were Caucasian. VA (letters) gains at 1‐year in treatment‐naïve patients receiving <3, 3–6, and >6 injections were 2.1 (n = 372), 3.6 (n = 1499), and 4.3 (n = 830), from baseline of 45.0, 52.5, and 54.9, respectively. In all treatment‐naïve nAMD patients, the mean ( SD ) gain in VA of 3.6 (16.2) at 1 year from 52.2 (20.8) at baseline was achieved with a mean ( SD ) of 5.3 (2.7) ranibizumab injections and 9.3 (3.3) monitoring visits. Across all treatment‐naïve nAMD patients (n = 6241), the incidence of ocular/non‐ocular AE s and SAE s were 8.2%/12.8% and 0.9%/7.4%, respectively. Conclusions This analysis from LUMINOUS confirms the effectiveness of ranibizumab in treatment‐naïve nAMD , and shows a relationship between VA improvement and the number of ranibizumab injections each patient received.