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Baseline characteristics of patients with retinal vein occlusion enrolled within the LUMINOUS study

Session Details

Session Title: Vascular Diseases and Diabetic Retinopathy I

Session Date/Time: Thursday 11/09/2014 | 08:00-10:00

Paper Time: 09:36

Venue: Boulevard C

First Author: : B.Burton UK

Co Author(s): :                  

Abstract Details

Purpose:

Ranibizumab (RBZ) 0.5 mg is approved for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO; branch or central) in many countries worldwide. Currently there are limited data on the use of RBZ in RVO patients in clinical practice. The LUMINOUS study (NCT01318941) is designed to assess the long-term safety, effectiveness, treatment-patterns and health-related quality-of-life associated with ranibizumab treatment in a real world setting. We describe the baseline characteristics of 241 RVO patients (BRVO, n=124; CRVO, n=117) from the first 10,071 patients enrolled into the LUMINOUS study

Setting:

The LUMINOUS study is an ongoing observational multicenter study, aiming to recruit 30,000 patients for all approved indications according to the local product label from 600 sites in over 41 countries worldwide. The overall duration of the study is 5 years, with a minimum 1-year follow up period per patient

Methods:

Consenting adult patients (treatment naïve or previously treated with ranibizumab or other ocular treatment) were enrolled. Exclusion criteria were simultaneous participation in another investigational study, or systemic/ocular vascular endothelial growth factor (VEGF) inhibitor administration (other than ranibizumab) in the 90 days prior to study enrolment. The study does not direct therapy or recommend treatment other than that patients are treated in accordance with the local approved indications on the product label. Timing of patient visits and subsequent treatment decisions are at the discretion of the treating physician. Here, we report the baseline demographics, ocular disease characteristics and key non-ocular comorbidities of the RVO patients enrolled within the LUMINOUS study

Results:

The BRVO/CRVO patients (n=124/117) had a mean age of 69.4/67.6 years, 82.3/ 85.5% were Caucasian; the proportion of male and female patients was 45.2 and 54.8%/63.2 and 36.8%. In BRVO/CRVO, 46/45 (37.1%/38.5%) patients did not have any ocular treatments prior to enrollment (T1), 62/52 (50.0%/44.4%) patients had previously received ranibizumab (T2), and 16/20 (patients had received other ocular treatments (T3). Pre-treatment status was defined by the primary treated eye. In BRVO and CRVO patients who had previously received ranibizumab (T2), 32.3% and 23.1% respectively had also previously received laser treatment, and 12.9% and 9.6% had received an anti-VEGF 12.9%/17.1%) other than ranibizumab. One patient with BRVO received bilateral treatment. The mean baseline visual acuity (VA, ETDRS letter score in the primary treated eye) for BRVO/CRVO was 37.3/38.9 (T1), 52.9/45.2 (T2) and 42.4/30.5 (T3) in the three groups. The mean central retinal thickness (CRT, μm) for BRVO/CRVO was 456.5/555.4 (T1), 328.8/365.9 (T2) and 558.7/460.4 (T3). The non-ocular comorbidities at baseline (T1, T2, T3; %) for BRVO/CRVO included hypertension (60.9/60.0, 59.7/61.5, 43.8/65.0), family history of coronary artery disease (13.0/8.9, 24.2/17.3, 6.3/15.0), myocardial infarction (2.2/4.4, 1.6/3.8, 0/10.0), stroke (6.5/8.9, 6.5/3.8, 0/5.0), and other thromboembolic events (6.5/2.2, 4.8/5.8, 0/10.0)

Conclusions:

The diversity of baseline demographic characteristics of the RVO patients enrolled in the LUMINOUS study is more representative of a real world patient population than highly selective randomised controlled trials with extensive inclusion/exclusion criteria. Patients who had received prior ranibizumab treatment had numerically higher VA and lower CRT baseline values than patients who were treatment-naïve. The LUMINOUS study data are expected to provide substantial evidence on the long-term safety, effectiveness, and treatment patterns of ranibizumab in routine clinical practice in the approved indications

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