[Early efficacy of dexamethasone implant (OZURDEX®) in diabetic macular edema: Real life study].
OBJECTIVE
To assess early efficacy of dexamethasone intravitreal implant 0.7mg (OZURDEX®) at the time of peak efficacy (2 months after injection) in patients with decreased visual acuity secondary to diabetic macular edema (DME).


METHODS
Retrospective monocentric study. Inclusion criteria were best-corrected visual acuity (BCVA)≤70 letters (20/40) due to DME and central retinal thickness (CRT)≥300 microns (Cirrus 2, Carl Zeiss Meditec, Inc, Dublin). Enrolled patients could be treatment naive or not (after failure of laser photocoagulation and/or anti-VEGF therapy). Follow-up was at least 6 months. Our primary endpoint was BCVA gain at M2 after injection. Secondary endpoints were best-corrected visual acuity at 2 and 4 months, central retinal thickness at 2 and 4 months, mean interval between 2 injections, and adverse events.


RESULTS
Nineteen eyes of 19 patients were included in this study. The mean age was 67.45 years, sex ratio was 2.17 men/women, and the patients were all type 2 diabetics. Three of 19 patients were treatment naive for anti-VEGF intravitreal injection, and 52.3% were pseudophakic (10/19 patients). The mean gain of BCVA at M2 was +7.7 letters. The mean BCVA was 51.1 ETDRS letters at baseline and 58.8 at M2. Mean CRT was 568.9μm at baseline and 291.2μm at M2. Treatment with dexamethasone implant was mainly a second-line treatment after failure of other treatments (macular laser photocoagulation and/or intravitreal injection of anti-VEGF). Three patients were naive of anti-VEGF treatment. Intraocular pressure≥25mmHg was found in 2 patients, and controlled medically. No glaucoma surgery was performed.


CONCLUSIONS
The dexamethasone implant (OZURDEX®) allows an anatomical and functional improvement in patients suffering from vision loss due to DME. In this series, the implant was well tolerated.
Service d'ophtalmologie, hôpital Avicenne, DHU vision et handicaps, 125, rue de Stalingrad, 93000 Bobigny, France.
V
V
Sarda
Service d'ophtalmologie, hôpital Avicenne, DHU vision et handicaps, 125, rue de Stalingrad, 93000 Bobigny, France; Centre ophtalmologique d'imagerie et de laser, 75015 Paris, France.
F
F
Fajnkuchen
Service d'ophtalmologie, hôpital Avicenne, DHU vision et handicaps, 125, rue de Stalingrad, 93000 Bobigny, France; Centre ophtalmologique d'imagerie et de laser, 75015 Paris, France.
S
S
Nghiem-Buffet
Service d'ophtalmologie, hôpital Avicenne, DHU vision et handicaps, 125, rue de Stalingrad, 93000 Bobigny, France; Centre ophtalmologique d'imagerie et de laser, 75015 Paris, France.
T
T
Grenet
Service d'ophtalmologie, hôpital Avicenne, DHU vision et handicaps, 125, rue de Stalingrad, 93000 Bobigny, France.
G
G
Chaine
Service d'ophtalmologie, hôpital Avicenne, DHU vision et handicaps, 125, rue de Stalingrad, 93000 Bobigny, France. Electronic address: audrey.giocanti@aphp.fr.
A
A
Giocanti-Auregan
D000368:Aged; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D003930:Diabetic Retinopathy / Q000188:drug therapy*; D004343:Drug Implants / Q000009:adverse effects; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects
D004343:Drug Implants; D005938:Glucocorticoids; D003907:Dexamethasone
Dexamethasone implant; Diabetic macular edema; Implant de dexaméthasone; Injections intra-vitréennes; Intravitreal injection; Real life; Étude de vraie vie; Œdème maculaire diabétique