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Baseline characteristics of diabetic macular edema patients enrolled within the LUMINOUS study

Poster Details

First Author: N.Patel UK

Co Author(s):                      0   0 0   0 0   0 0   0 0

Abstract Details



Purpose:

Several clinical trials have demonstrated the efficacy and safety of ranibizumab in patients with diabetic macular edema (DME). However, there are limited data originating from the use of ranibizumab in patients in real world clinical practice. Here, we describe the baseline characteristics of the 454 patients with visual impairment due to DME from the first 10,071 patients enrolled into the LUMINOUS study

Setting:

The LUMINOUS study (NCT01318941) is an ongoing 5-year observational multicenter study currently conducted in over 30 countries where ranibizumab 0.5 mg is approved, designed to assess the long-term safety, effectiveness, treatment-patterns and health-related quality-of-life associated with ranibizumab treatment for any approved indication included in the local product label

Methods:

We report the baseline demographics, ocular disease characteristics and key non-ocular comorbidities of the first cohort of DME patients enrolled within the LUMINOUS study. Consenting adult patients (treatment naïve, or previously treated with ranibizumab or other ocular treatments) 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

Results:

The DME patients (n=454) had a mean age of 64.4 years, 88.5% were Caucasian, 52.2% were males, and 47.8% were female. A total of 136 (30.0%) patients did not have any ocular treatments prior to enrollment (T1, treatment naïve), 178 (39.2%) patients had previously received ranibizumab (T2, treatment non-naïve ranibizumab), and 140 (30.8 %) had received other ocular treatments (T3, treatment non-naïve others). HbA1C levels were 9.0% (T1), 7.6% (T2), and 8.0% (T3). The mean time from diagnosis of DME to first treatment was 1.2 years for T1 and the mean time from diagnosis to study entry was 2.1 years for T2 and 1.0 year for T3. Of the treatment non-naïve patients, 52.8% (T2), and 97.9% (T3) had received prior laser treatment. The mean baseline visual acuity (VA, ETDRS letter score) was 40.8 (T1), 55.3 (T2) and 52.8 (T3). The mean central retinal thickness (CRT, μm) was 429.3 (T1), 371.5 (T2) and 430.2 (T3). Non-ocular comorbidities at baseline (T1, T2, T3; %) included hypertension (53.7, 68.5, 69.3), obesity (14.7, 24.2, 19.3), family history of coronary artery disease (11.8, 19.7, 17.1), myocardial infarction (7.4, 6.7, 9.3), stroke (5.1, 10.7, 5.0), and other thromboembolic events (1.5, 5.1, 2.1)

Conclusions:

The diversity of baseline demographic characteristics of the DME patients enrolled in the LUMINOUS study is more representative of a real world patient population than observed in clinical studies. Prior ranibizumab treatment was associated with numerically higher VA and lower CRT baseline values than patients who were treatment-naïve. Analyses of 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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