Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France

Abstract

Purpose: To evaluate patterns of use and long-term efficacy and safety of dexamethasone intravitreal implant (DEX implant) in the treatment of macular edema secondary to branch or central retinal vein occlusion (BRVO, CRVO) in French clinical practice.

Methods: A 24-month, prospective, multicenter, longitudinal, observational study (LOUVRE) conducted at 48 randomly selected sites in metropolitan France enrolled consecutive adult patients with macular edema following retinal vein occlusion (RVO) who were treated with DEX implant at baseline. Re-treatment with DEX implant and use of other RVO treatments was at the physician's discretion. The primary endpoint was the change in best-corrected visual acuity (BCVA) from baseline to month 6. Secondary endpoints included change in BCVA, intraocular pressure (IOP), adverse events, and RVO treatments administered through month 24.

Results: The analysis population of 375 patients (53.9 % BRVO, 46.1 % CRVO) received a mean of 2.6 DEX implant injections over 2 years; mean time between injections was 6.6 months. Mean (SD) change in BCVA from baseline was 5.1 (19.0) letters at month 6 (p < 0.001) and 4.6 (22.3) letters at month 24 (p < 0.001). During the study, 208 patients (55.5 %) received treatment other than DEX implant for RVO, usually laser or ranibizumab therapy, with first use of other therapy occurring at a mean of 8.7 months. Mean change from baseline BCVA at month 6 was 5.5 letters (p < 0.001, N = 254) in patients who had received only DEX implant and 4.2 letters (p = 0.006, N = 121) in patients who had received additional other RVO treatment during the first 6 months. At month 24, mean change from baseline BCVA was +20.7 letters in patients treated with a single DEX implant only (p < 0.001), +4.9 letters in patients treated with ≥2 DEX implants only (p = 0.029), and +2.3 letters in patients treated with DEX implant and other RVO treatment (p = 0.143). The most common adverse events (incidence) were cataract progression (39.7 %) and increased IOP (34.4 %). No glaucoma incisional surgeries were required.

Conclusions: Efficacy and safety of DEX implant in the treatment of RVO-associated macular edema were demonstrated in the French clinical setting. Patients who switched from DEX implant to other RVO treatments did not have improved outcomes. The study is registered at ClinicalTrials.gov with the identifier NCT01618266.

Keywords: Dexamethasone; Intravitreal; Macular edema; Observational; Prospective; Retinal vein occlusion.

Conflict of interest statement

Compliance with ethical standards Funding and competing interests This study was sponsored by Allergan plc (Dublin, Ireland). J.-F. Korobelnik is a consultant to Alcon, Alimera, Allergan, Bayer, Horus, Novartis, Roche, Thea, and Zeiss. L. Kodjikian serves on an advisory board and as a lecturer and investigator for Allergan. C. Delcourt has received research grants from Laboratoires Théa, is an advisory board member for Bausch + Lomb, Laboratoires Théa, and Novartis, and is consultant to Allergan. V. Gualino is an investigator for Allergan. S. Pinchinat is an employee of Biostatem. R. Leaback and M.-E. Velard are employees of Allergan. The authors have full control of all primary data, and they agree to allow Graefe’s Archive for Clinical and Experimental Ophthalmology to review their data upon request. Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Figures

Fig. 1

Patient flow through the study. BCVA Best-corrected visual acuity, DEX implant Dexamethasone intravitreal implant

Fig. 2

Mean BCVA in study eye. a Total analysis population. b Subgroups based on all RVO treatments received during the study. Error bars show 95 % confidence interval. BCVA best-corrected visual acuity, D day, DEX implant dexamethasone intravitreal implant, M month, RVO retinal vein occlusion, W week

Fig. 3

Mean CRT in study eye. a Total analysis population. b Subgroups based on all RVO treatments received during the study. Error bars show 95 % confidence interval. CRT central retinal thickness, DEX implant dexamethasone intravitreal implant, M month, RVO retinal vein occlusion, Sc screening, W week

Fig. 4

Mean IOP in study eye. a Total analysis population. b Subgroups based on all RVO treatments received during the study. Error bars show 95 % confidence interval. D day, DEX implant dexamethasone intravitreal implant, IOP intraocular pressure, M month, RVO retinal vein occlusion, W week