ETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema

To evaluate the real-world effectiveness of intravitreal ranibizumab 0.5 mg (Lucentis) in improving visual acuity (VA) in adults with decreased VA due to diabetic macular edema (DME). Real-world prospective observational 24-month study. Ranibizumab-naïve patients (n=116) were enrolled, treated and f...

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Published in:Clinical ophthalmology (Auckland, N.Z.) N.Z.), 2021-01, Vol.15, p.2307-2315
Main Authors: Kodjikian, Laurent, Lecleire-Collet, Amélie, Dot, Corinne, Le Lez, Marie-Laure, Baillif, Stéphanie, Erginay, Ali, Souied, Eric, Fourmaux, Eric, Gain, Philippe, Ponthieux, Anne
Format: Article
Language:English
Subjects:
Analysis
Care and treatment
Demographics
Diabetes
Diabetic retinopathy
Dropsy
Edema
Hyperglycemia
Hypoxia
induction
Medical personnel
Medical research
Medicine, Experimental
Monoclonal antibodies
Original Research
Patients
Permeability
Pharmaceutical industry
Population
real-world study
retinal thickness
Sensitivity analysis
Surveillance
switch
Variance analysis
Vascular endothelial growth factor
visual acuity
Visual impairment
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Gain, Philippe
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description To evaluate the real-world effectiveness of intravitreal ranibizumab 0.5 mg (Lucentis) in improving visual acuity (VA) in adults with decreased VA due to diabetic macular edema (DME). Real-world prospective observational 24-month study. Ranibizumab-naïve patients (n=116) were enrolled, treated and followed up according to investigators' usual procedures. Outcomes included change from baseline to month 24 in best-corrected VA (BCVA; primary outcome), central retinal thickness (CRT), treatment exposure and safety. Overall, 62.9% of patients completed the study per protocol, 68.6% completed the induction phase (first three injections one month apart). On average, patients had 12.5 ophthalmologist visits and 5.74 injections in year 1, decreasing to 4.6 visits and 1.94 injections in year 2. Mean baseline BCVA was 58.4 letters, mean gain at M24 was +6.08 letters (95% CI: 2.95, 9.21). Gains were higher for patients who completed induction, and for patients who did not switch treatment. Mean CRT improved by 149.17 μm at M24. There were no new safety signals. BCVA variation of ≥6 letters by M3 was predictive of BCVA gains at M24 (p=0.007), as was hypertension medication at baseline (p=0.022). Real-world ranibizumab treatment improved VA in DME patients, despite fewer injections than recommended.
doi_str_mv 10.2147/OPTH.S313081
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source Taylor & Francis Open Access; Publicly Available Content Database; PubMed Central
subjects Analysis
Care and treatment
Demographics
Diabetes
Diabetic retinopathy
Dropsy
Edema
Hyperglycemia
Hypoxia
induction
Medical personnel
Medical research
Medicine, Experimental
Monoclonal antibodies
Original Research
Patients
Permeability
Pharmaceutical industry
Population
real-world study
retinal thickness
Sensitivity analysis
Surveillance
switch
Variance analysis
Vascular endothelial growth factor
visual acuity
Visual impairment
title ETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema
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