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
| Autor: | Pierre-Jean Guillausseau, Cécile Delcourt, Laurent Kodjikian, Jean-François Girmens, Agnès Glacet-Bernard, Anne Ponthieux, Angela Grelaud, Pascale Massin, Catherine Creuzot-Garcher, Patrick Blin, F. Fajnkuchen |
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| Přispěvatelé: | Institut des Sciences de la mécanique et Applications industrielles (IMSIA - UMR 9219), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-École Nationale Supérieure de Techniques Avancées (ENSTA Paris)-Centre National de la Recherche Scientifique (CNRS)-Université Paris-Saclay-EDF R&D (EDF R&D), EDF (EDF)-EDF (EDF), Service d'Ophtalmologie (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Matériaux, ingénierie et science [Villeurbanne] (MATEIS), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS), Service d'urologie [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Centre d’imagerie et de laser, Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), VEOLIA RECHERCHE ET INNOVATION (VERI), CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-École Nationale Supérieure de Techniques Avancées (ENSTA Paris)-Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS)-EDF R&D (EDF R&D), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Veolia Recherche & Innovation (VeRI), Veolia Environnement (FRANCE) |
| Rok vydání: | 2019 |
| Předmět: |
Male
drug safety Visual acuity genetic structures very elderly visual impairment Visual Acuity Angiogenesis Inhibitors [SPI.MAT]Engineering Sciences [physics]/Materials 0302 clinical medicine 80 and over Prospective Studies Prospective cohort study pathophysiology Aged 80 and over retina macula hole General Medicine Diabetic retinopathy Middle Aged cohort analysis sample size Sensory Systems clinical practice 3. Good health retina hemorrhage priority journal diabetes mellitus Intravitreal Injections central macular thickness ophthalmologist Female medicine.symptom diabetic macular edema prospective study Cohort study medicine.drug Adult posterior reversible encephalopathy syndrome medicine.medical_specialty hypertension epistaxis heart infarction Vision Disorders visual disorder Article Macular Edema 03 medical and health sciences Cellular and Molecular Neuroscience Retina hemorrhage Ranibizumab Ophthalmology best corrected visual acuity medicine Humans human Macular edema Aged Diabetic Retinopathy business.industry clinical effectiveness intravitreal drug administration medicine.disease major clinical study eye diseases Confidence interval multicenter study angiogenesis inhibitor physiology central subfield thickness treatment outcome 030221 ophthalmology & optometry observational study business 030217 neurology & neurosurgery |
| Zdroj: | Ophthalmic Research Ophthalmic Research, 2019, 62 (2), pp.101-110. ⟨10.1159/000497406⟩ |
| ISSN: | 1423-0259 0030-3747 |
| DOI: | 10.1159/000497406 |
| Popis: | 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, 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. 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. |
| Databáze: | OpenAIRE |
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