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ACTIVE NOT RECRUITING
NCT04116398
PHASE2

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

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

Nowadays, steroids and anti-VEGF are the first line treatment for diabetic macular edema. Ozurdex is the most frequently used steroid and has label for both first and second line treatment. Ozurdex treatment paradigm for patients with diabetic macular edema is to inject patient only in case of huge recurrence. The risk of this scheme is a progressive loss of vision due to photoreceptors loss. A more pro-active regimen, as it already exists for anti-VEGF treatment, would allow a better patient management. A new treatment paradigm consisting in a loading dose of 2 injections within 12 weeks, followed by a PRN (Pro Re Nata) regimen with strict retreatment criteria and minimal time limit of 12 weeks between two injections should result in a better visual acuity gain and a limited augmentation of the number of injections (which will remain lower than the number observed for anti-VEGF treatment). The investigators have therefore chosen a pilot study to investigate the impact on efficacy and on the number of intravitreal injections (IVI) of such a scheme.

Official title: Pilot and Phase 2 Study of the Efficacy of a Treatment Protocol With Dexamethasone Implant Loading Dose in Patients With Diabetic Macular Edema

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2020-11-30

Completion Date

2026-12

Last Updated

2025-11-19

Healthy Volunteers

No

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)

Locations (16)

APHP - Hôpital Avicenne

Bobigny, France

CHU Bordeaux - Hôpital Pellegrin

Bordeaux, France

Centre Rétine Gallien

Bordeaux, France

Hôpital Intercommunal de Créteil

Créteil, France

CHU Dijon

Dijon, France

CHRU Lille - Hôpital Huriez

Lille, France

Hôpital Edouard Herriot

Lyon, France

Hospices Civils de Lyon - Hopital de la Croix Rousse

Lyon, France

Centre Monticelli Paradis d'ophtalmologie

Marseille, France

APHM - Hôpital Nord

Marseille, France

Clinique Juge

Marseille, France

APHP - Hôpital Lariboisière

Paris, France

Centre Hospitalier National d'Ophtalmologie des XV XX

Paris, France

CHU de Poitiers - La miletrie

Poitiers, France

Clinique Mathilde

Rouen, France

CHU Toulouse - Hôpital Pierre Paul Riquet

Toulouse, France