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Christopher S Brand, ; Baseline characteristics of over 10,000 patients enrolled into the LUMINOUS study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3061.
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© ARVO (1962-2015); The Authors (2016-present)
To describe baseline characteristics of over 10,000 patients recruited in the LUMINOUS study
LUMINOUS is a 5-year multicenter, prospective study to evaluate long-term safety, effectiveness, treatment patterns, and health-related quality of life in patients treated in routine clinical practice with 0.5 mg ranibizumab (RBZ) in wet age-related macular degeneration [wAMD], diabetic macular edema [DME], retinal vein occlusion [RVO], and myopic choroidal neovascularization [mCNV] (depending on local approval). Consenting adult patients are enrolled irrespective of whether or not they were previously treated with RBZ and/or any other ocular therapy. Patients are excluded if they are participating in any other study that includes administration of any investigational drug, or have had systemic or ocular treatment with any vascular endothelial growth factor inhibitor other than RBZ, 90 days prior to study enrolment. The study is planned to recruit 30,000 patients from approximately 600 sites in 41 countries worldwide
As of December 2013, baseline data were available for 10,071 patients. Demographic data are shown in table 1 and comorbidities in table 2. In total, 7914 (78.6%) patients were previously treated with RBZ (T1), 1891 (18.8%) patients did not have any prior treatment (T2), and 266 (2.6%) were previously treated with other ocular therapies (T3; the pre-treatment status refers to the primary treated eye). Here we present the data of T1 and T2 groups. The baseline mean visual acuity (VA) letter score of the study eye was higher in the T1 group than the T2 group across all indications (wAMD: 55.6 vs 46.4; DME: 55.3 vs 40.8; BRVO: 52.9 vs 37.3; CRVO: 45.2 vs 38.9). Mean central retinal thickness (CRT; µm) of the study eye at baseline was lower in T1 than T2 across all indications (wAMD: 265.6 vs 347.3; DME: 371.5 vs 429.3; BRVO: 328.8 vs 456.5; CRVO: 365.9 vs 555.4)
LUMINOUS includes patients with more diverse demographics than reported for the pivotal trials and is more representative of real world wAMD, DME and RVO patients. Previous treatment with RBZ was associated with higher VA and lower CRT at baseline than in the group without prior treatment across indications
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