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.
OBJECTIVE
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.
Service d'Ophtalmologie, CHU de Bordeaux, Bordeaux, France. jean-francois.korobelnik@chu-bordeaux.fr.|Univ. Bordeaux, ISPED, F-33000, Bordeaux, France. jean-francois.korobelnik@chu-bordeaux.fr.|Inserm, U1219 - Bordeaux Population Health Research Center, F-33000, Bordeaux, France. jean-francois.korobelnik@chu-bordeaux.fr.
Jean-François
JF
Korobelnik
La Croix-Rousse Hospital, University Hospital of Lyon, Lyon, France.
Laurent
L
Kodjikian
Univ. Bordeaux, ISPED, F-33000, Bordeaux, France.|Inserm, U1219 - Bordeaux Population Health Research Center, F-33000, Bordeaux, France.
Cécile
C
Delcourt
Clinique Honoré Cave, Montauban, France.
Vincent
V
Gualino
Allergan plc, Marlow, UK.
Richard
R
Leaback
Biostatem, Castries, France.
Sybil
S
Pinchinat
Allergan plc, Courbevoie, France.
Marie-Eve
ME
Velard
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003907:Dexamethasone / Q000008:administration & dosage*; D004343:Drug Implants; D005260:Female; D005500:Follow-Up Studies; D005602:France; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012170:Retinal Vein Occlusion / Q000150:complications* / Q000188:drug therapy; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity
D004343:Drug Implants; D005938:Glucocorticoids; D003907:Dexamethasone
Dexamethasone; Intravitreal; Macular edema; Observational; Prospective; Retinal vein occlusion