Name
060 - Traitement par ranibizumab de l’œdème maculaire des Occlusions de la Veine Centrale de la Rétine en pratique de routine en France: résultats à 24 mois de l’étude BOREAL-OVCR

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Orateurs :
Agnes Glacet Bernard
Tags :
Congrès SFO 2018
2018
Résumé

Introduction

To assess the effectiveness and safety of ranibizumab 0.5 mg in French patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) from the 24-month BOREAL-CRVO study.

Patients et Methodes

This is a multicenter, post-authorization, observational cohort study conducted in France. Adult patients (aged ≥18 years) with a confirmed diagnosis of CRVO and for whom ranibizumab therapy was initiated were included in the study. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) at Month 6 compared with baseline. Key secondary endpoints were the mean change in BCVA at M24 vs baseline, mean change in central subfield thickness (CSFT) at Month 6 and 24 and treatment exposure to ranibizumab.

Résultats

Of the 196 enrolled patients, the mean (standard deviation [SD]) age of the patients was 70.4 (14.3) years at baseline and 51.5% were male. The mean baseline BCVA and CSFT were 40.4 (25.6) letters and 643 (218) μm, respectively. At Month 6, the mean change in BCVA from baseline was 9.5 letters [95%CI: 5.5, 13.5], with 35.7% of patients with BCVA >70 letters vs 8.2% at baseline. Vision was maintained at Month 12 and 24 with a mean change in BCVA from baseline respectively of 9.2 letters [95%CI: 4.5, 13.9] and 8.3 letters [95%CI: 3.7, 12.8] with 33.8% and 38.9% of patients with BCVA >70 letters respectively. The mean (SD) change in CSFT at Month 6, 12 and 24 from baseline was −267 μm, −284 μm and −305 μm, respectively. In the first year, the mean (SD) number of ranibizumab injections in the study eye was 5.1 (2.4) with 10.1 (2.8) visits whereas in the second year, patients received a mean of 1.9 (2.7) injections with 6.8 (3.4) visits. No new safety findings were identified.

Discussion

 

 

Conclusion

The results of the BOREAL CRVO study help to define the effectiveness of ranibizumab in patients with macular edema secondary to CRVO in a real-world setting.