53
Participants
Start Date
November 30, 2020
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2026
Dexamethasone with 2 loading doses followed by PRN regimen.
"* Loading dose with 2 systematic intravitreal injections (IVI) of ozurdex at the baseline and 12 weeks.Followed by a PRN regimen with strict retreatment criteria (already used and published in the Prediamex study, Bellocq,Kodjikian et al Ophthalmology Retina 2017)~* Retreatment criteria: Reduction in VA ≥ 5 ETDRS Letters; and/or CSMT ≥ 275 microns by OCT-Cirrus® or ≥ 285 microns by OCT Spectralis®/Topcon; and/or increase of CSMT \> 50 microns; and/or onset of recurrent retinal cysts; and/or residual edema considered by the practitioner to be clinically significant.~* Minimal time limit between two IVI : 12 weeks~* Visits: monthly during 1 year (to check efficacy and safety) and then for the 2nd-year only at Month18 (M18) and Month 24 (M24)"
Centre Monticelli Paradis d'ophtalmologie, Marseille
APHM - Hôpital Nord, Marseille
CHU Dijon, Dijon
CHU Toulouse - Hôpital Pierre Paul Riquet, Toulouse
CHU Bordeaux - Hôpital Pellegrin, Bordeaux
CHRU Lille - Hôpital Huriez, Lille
Hôpital Edouard Herriot, Lyon
Hospices Civils de Lyon - Hopital de la Croix Rousse, Lyon
APHP - Hôpital Lariboisière, Paris
Centre Hospitalier National d'Ophtalmologie des XV XX, Paris
CHU de Poitiers - La miletrie, Poitiers
APHP - Hôpital Avicenne, Bobigny
Hôpital Intercommunal de Créteil, Créteil
Centre Rétine Gallien, Bordeaux
Clinique Juge, Marseille
Clinique Mathilde, Rouen
Hospices Civils de Lyon
OTHER