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
Résumé
Purpose: To report the real-world effectiveness and safety of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (DME). Methods: 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, preci sion = 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. Results: 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. Conclusions: 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. © 2019 S. Karger AG, Basel.
Mots clés
retina hemorrhage
retina macula hole
intravitreal drug administration
pathophysiology
physiology
prospective study
very elderly
visual disorder
Adult
Aged
80 and over
Angiogenesis Inhibitors
Diabetic Retinopathy
Female
Humans
Intravitreal Injections
Macular Edema
Male
Middle Aged
Prospective Studies
Ranibizumab
Vision Disorders
Visual Acuity
epistaxis
heart infarction
human
drug safety
diabetic macular edema
diabetes mellitus
cohort analysis
clinical practice
clinical effectiveness
central subfield thickness
central macular thickness
best corrected visual acuity
sample size
treatment outcome
visual impairment
angiogenesis inhibitor
Article
hypertension
major clinical study
multicenter study
observational study
ophthalmologist
posterior reversible encephalopathy syndrome
priority journal