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Ophthalmic Res. 2019;62(2):101-110. doi: 10.1159/000497406. Epub 2019 Mar 29.

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.

Author information

1
Ophthalmology, Hopital Lariboisière, Paris, France.
2
Ophthalmology, University Hospital, Dijon, France.
3
Ophthalmology, Hopital de la Croix Rousse, Lyon University, UMR CNRS MATEIS 5510, Lyon, France.
4
Ophthalmology, CHNO des Quinze-Vingts, Paris, France.
5
Inserm U1219 - Bordeaux Population Health Research Center, University of Bordeaux, Bordeaux, France.
6
Ophthalmology, Hôpital Avicenne, Bobigny, France.
7
Ophthalmology, Centre Hospitalier Intercommunal de Créteil, Paris-Est Créteil University, Créteil, France.
8
Internal Medicine, Hopital Lariboisière, Paris, France.
9
Novartis Pharma SAS, Rueil-Malmaison, France, anne.ponthieux@novartis.com.
10
Bordeaux PharmacoEpi, INSERM CIC1401, Université de Bordeaux, Bordeaux, France.

Abstract

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.

KEYWORDS:

BOREAL; Best-corrected visual acuity; Central subfield thickness; Diabetic macular edema; Early Treatment Diabetic Retinopathy Study; Ranibizumab; Real-world outcomes

PMID:
30928985
DOI:
10.1159/000497406
[Indexed for MEDLINE]

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