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. 2021 Jun 3:15:2307-2315.
doi: 10.2147/OPTH.S313081. eCollection 2021.

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

Laurent Kodjikian  1 , Amélie Lecleire-Collet  2 , Corinne Dot  3 , Marie-Laure Le Lez  4 , Stéphanie Baillif  5 , Ali Erginay  6 , Eric Souied  7 , Eric Fourmaux  8 , Philippe Gain  9 , Anne Ponthieux  10
Affiliations

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

Laurent Kodjikian et al. Clin Ophthalmol. .

Abstract

Purpose: 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).

Patients and methods: 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.

Results: 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).

Conclusion: Real-world ranibizumab treatment improved VA in DME patients, despite fewer injections than recommended.

Keywords: induction; real-world study; retinal thickness; switch; visual acuity.

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Conflict of interest statement

AP is an employee of Novartis Pharma SAS, France. LK received consulting fees from Novartis related to the current paper and reports personal fees from Allergan, AbbVie, Alimera, Horus, Bayer, Novartis, Roche, and Thea, during the conduct of the study. ALC reports payment for enrollment of patients and data from Novartis, during the conduct of the study; consultant for Novartis, Bayer, and Allergan, outside the submitted work. CD reports personal fees for consulting from AbbVie, Bayer, Novartis, and Horus, during the conduct of the study. SB is a board member for Allergan, Novartis, Bayer and Horus Pharma, outside the submitted work. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Flow chart of patients in study.
Figure 2
Figure 2
Change from baseline in (A) visual acuity and, (B) central retinal thickness.
Figure 3
Figure 3
Change from baseline in (A) visual acuity and (B) central retinal thickness, according to completion of induction phase.
Figure 4
Figure 4
Change from baseline in visual acuity in patients (A) without and (B) with treatment switch, and change from baseline in central retinal thickness in patients (C) without and (D) with treatment switch.
See this image and copyright information in PMC

References

    1. Klein R, Lee KE, Gangnon RE, Klein BE. The 25-year incidence of visual impairment in type 1 diabetes mellitus the Wisconsin epidemiologic study of diabetic retinopathy. Ophthalmology. 2010;117:63–70. doi:10.1016/j.ophtha.2009.06.051 - DOI - PMC - PubMed
    1. Moss SE, Klein R, Klein BE. Ten-year incidence of visual loss in a diabetic population. Ophthalmology. 1994;101:1061–1070. doi:10.1016/S0161-6420(94)31217-6 - DOI - PubMed
    1. Yau JW, Rogers SL, Kawasaki R, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35:556–564. doi:10.2337/dc11-1909 - DOI - PMC - PubMed
    1. Massin P, Bandello F, Garweg JG, et al. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter Phase II study. Diabetes Care. 2010;33:2399–2405. doi:10.2337/dc10-0493 - DOI - PMC - PubMed
    1. Prünte C, Fajnkuchen F, Mahmood S, et al. Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study. Br J Ophthalmol. 2016;100::787–795. doi:10.1136/bjophthalmol-2015-307249 - DOI - PMC - PubMed