Pilot and Phase 2 Study of the Efficacy of a Treatment Protocol With Dexamethasone Implant Loading Dose in Patients With Diabetic Macular Edema (LOADEX)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

November 30, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Diabetic Macular Edema
Interventions
DRUG

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)"

Trial Locations (16)

13008

Centre Monticelli Paradis d'ophtalmologie, Marseille

13015

APHM - Hôpital Nord, Marseille

21079

CHU Dijon, Dijon

31059

CHU Toulouse - Hôpital Pierre Paul Riquet, Toulouse

33000

CHU Bordeaux - Hôpital Pellegrin, Bordeaux

59037

CHRU Lille - Hôpital Huriez, Lille

69003

Hôpital Edouard Herriot, Lyon

69004

Hospices Civils de Lyon - Hopital de la Croix Rousse, Lyon

75010

APHP - Hôpital Lariboisière, Paris

75012

Centre Hospitalier National d'Ophtalmologie des XV XX, Paris

86000

CHU de Poitiers - La miletrie, Poitiers

93000

APHP - Hôpital Avicenne, Bobigny

94010

Hôpital Intercommunal de Créteil, Créteil

Unknown

Centre Rétine Gallien, Bordeaux

Clinique Juge, Marseille

Clinique Mathilde, Rouen

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER