Real-World Outcomes with Ranibizumab 0.5 mg in Patients with Visual Impairment due to Diabetic Macular Edema: 12-Month Results from the 36-Month BOREAL-DME Study

Abstract

<b><i>Purpose:</i></b> To report the real-world effectiveness and safety of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (DME). <b><i>Methods:</i></b> This is a French, 36-month, multicenter, observational cohort study. Between December 2013 and April 2015, ophthalmologists enrolled diabetic patients aged ≥18 years with DME-related visual impairment and for whom ranibizumab 0.5 mg was initiated. Here, we present the 12-month results from this cohort. The primary endpoint was the mean change in best-corrected visual acuity (BCVA); sample size calculations were based on RESTORE trial data (BCVA mean change = 6.8 letters, precision = 0.7 letters). Secondary endpoints included the change in central subfield thickness (CSFT), number of visits, number of injections received, and frequency of ocular and nonocular adverse events and serious adverse events. <b><i>Results:</i></b> Between December 2013 and April 2015, a total of 290 patients with DME were enrolled by 84 ophthalmologists; 12-month data are available for 242 patients (due to low recruitment rates, precision was recalculated for 242 evaluable patients: the precision was then of 1.0 letters). Mean age (± standard deviation) was 66.1 ± 11.0 years and 56.6% were male. The mean baseline BCVA and CSFT were 59.2 letters (95% confidence interval [CI] 57.3, 61.0) and 457 μm (95% CI: 438, 476), respectively. At month 12, the mean gain in BCVA from baseline was 7.4 letters (95% CI: 5.4, 9.4), with 36.8% of patients with BCVA >70 letters versus 13.2% at baseline. Mean change in CSFT was −125 μm (95% CI: −146, −103). The mean number of ranibizumab injections was 5.1 ± 2.3 over an average of 10.4 ± 3.0 visits. No new safety findings were identified. <b><i>Conclusions:</i></b> The BOREAL study confirms the effectiveness and safety of ranibizumab for the treatment of DME-related visual impairment in routine clinical practice with fewer injections than reported in clinical trials.

INVICTUS: Intravitreal anti-VEGF and dexamethasone implant comparison for the treatment of diabetic macular edema: A 12 months follow-up study

“…14 Our anti-VEGF 12-month visual outcomes confirm the recent results from BOREAL study in real-world of +7.4 letters with RAN for DME. 15…”

Cost-consequence analysis of extended loading dose of anti-VEGF treatment in diabetic macular edema patients

“…This analysis is not without limitations. Although the Protocol T study was carried out with patients from the United States, the patient characteristics of anti-VEGF treated patients are very similar between Western countries, as shown in several published case series studies carried out in Europe and US [20][21][22][23][24][25][26]. A multicenter US study included patients treated with the 3 available anti-VEGF therapies with a mean age of 63.4 years and 80.8% with type 2 diabetes.…”

“…A multicenter study carried out in Australia and several European countries reported a mean participant age of 62–65 years; most of them had type 2 diabetes, a mean BCVA of 64–67 letters and a CRT of 407–433 μm [ 22 ]. In a multicenter study carried out in France, anti-VEGF-treated patients had a mean age of 66.1 years, 83.5% has type 2 diabetes, and they had a mean BCVA of 59.2 letters and a CRT of 457 μm [ 23 ]. In the Spanish setting, a retrospective study compared the baseline characteristics of a cohort of Spanish patients from clinical practice who started treatment with ranibizumab with the cohorts from randomized clinical trials, including Protocol T, and real-world studies.…”

Real-World Outcomes after 36-Month Treatment with Ranibizumab 0.5 mg in Patients with Visual Impairment due to Diabetic Macular Edema (BOREAL-DME)

“…This study was mandated by the French Transparency Commission during the approval of ranibizumab reimbursement in DME, with the aim of providing data on the efficacy, safety, and follow-up in a real-life setting in DME patients initiating treatment with ranibizumab. The year 1 results of this study demonstrated the efficacy and safety of ranibizumab treatment, and no new ocular or nonocular safety concerns were observed [8]. Here, we describe the results of a 3-year postauthorization study of ranibizumab in DME.…”

“…Data were obtained from the medical records of participants by investigators or their delegates at inclusion and at every medical visit (usually every 3 months) up to month 36 (M36). The variables of interest were described previously [8]. Briefly, the data recorded at the inclusion visit were demographics, diabetes and ocular disease characteristics, comorbidities, treatment details, and adverse events (AEs).…”