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

NCT04116398 | Active Not Recruiting Phase 2 DMC

• 3 other identifiers: 69HCL19_05882019-003092-182024-514362-39-00
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Diabetic Macular Edema

Keywords

dexamethasone,; loading dose,; diabetic macular edema; pseudophakic

Outcome Measures

Primary Outcomes (1)

• Maximum BCVA (Best Corrected Visual Acuity) change (best improvement) from baseline (during one year of treatment)

  Best Corrected Visual Acuity (BCVA) is measured on the ETDRS scale at an initial distance of 4 meters.

  52 weeks

Secondary Outcomes (37)

• The time required to obtain the best BCVA

  52 weeks

• The number of injections required to obtain the best BCVA

  52 weeks

• the maximum best corrected visual acuity (BCVA) change (best improvement) measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale

  between the baseline and 1,5 years and between the baseline and 2 years

• values of Visual Acuity (VA) at each visit

  all visits during 2 years

• Area under the curve (AUC) of VA

  between the baseline and 52 weeks and between the baseline and 2 years

Study Arms (1)

Ozurdex®, 700µg dexamethasone intravitreal injection

EXPERIMENTAL

Intravitreal injection of dexamethasone (Ozurdex®)

Drug: Dexamethasone with 2 loading doses followed by PRN regimen.

Interventions

Dexamethasone with 2 loading doses followed by PRN regimen. DRUG

* 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)

Ozurdex®, 700µg dexamethasone intravitreal injection

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient \> 40 years old
• Patient for which a dexamethasone implant is chosen
• % naive eyes (no history of steroids or anti-VEGF)
• Pseudophakic for at least 3 months
• HBA1c \< 10%
• Blood pressure \< 160/95
• Patient who give voluntary signed informed consent
• Patient affiliated with the French universal health care system or similar
• Patient able to participated in all visits and medical examinations during the study
• If both eyes have to be treated, only one eye will be included : the eye with the lowest visual acuity at the baseline

You may not qualify if:

• Aphatic eye without posterior lens capsule.
• Study eye with implant anterior chamber of the eye or intraocular implant with iris fixated or transsclerally or ruptured posterior lens capsule.
• Study eye with lens implant ARTISAN®
• Ocular or periocular infection active or suspected in the study eye including most viral diseases of the cornea and conjunctiva, epithelial keratitis active Herpes simplex (dendritic keratitis), vaccinia, chickenpox, mycobacterial infections and mycoses
• Delay after last session of panretineal Photocoagulation laser \< 1 month in the study eye
• Delay after last focal laser session of the posterior pole \< 1 month in the study eye
• Vitreomacular traction syndrome, associated ERM in the study eye
• History of macular grid laser in the study eye
• Focal laser only if the scars are located within 750 microns of the center (1/2 Papillary Diameter) in the study eye
• Ischemic maculopathy (increase of more than 2 times the surface of the central avascular zone)
• Proliferative diabetic Retinopathy in the study eye
• Hypertension or Open Angle Glaucoma (OAG) treated by dual therapy eye drops or more
• Patients with a systemic pathology that could interfere in the evolution of the Diabetic Macular Edema and treated by with immunosuppressive drugs, systemic steroids, anti-aldosterone or systemic anti-VEGF.
• Hypersensitivity to the active substance or to any of the excipients and to anesthetic or hypotonizing eye drops
• History of any pathology, metabolic disease, or any serious suspicion of disease at clinical or laboratory examination that contraindicates the use of the intra-retinal dexamethasone implant, could affect the interpretation of the results of the study or cause significant risks of complication for the subject

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (16)

APHP - Hôpital Avicenne

Bobigny, 93000, France

Location

CHU Bordeaux - Hôpital Pellegrin

Bordeaux, 33000, France

Location

Centre Rétine Gallien

Bordeaux, France

Location

Hôpital Intercommunal de Créteil

Créteil, 94010, France

Location

CHU Dijon

Dijon, 21079, France

Location

CHRU Lille - Hôpital Huriez

Lille, 59037, France

Location

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Hospices Civils de Lyon - Hopital de la Croix Rousse

Lyon, 69004, France

Location

Centre Monticelli Paradis d'ophtalmologie

Marseille, 13008, France

Location

APHM - Hôpital Nord

Marseille, 13015, France

Location

Clinique Juge

Marseille, France

Location

APHP - Hôpital Lariboisière

Paris, 75010, France

Location

Centre Hospitalier National d'Ophtalmologie des XV XX

Paris, 75012, France

Location

CHU de Poitiers - La miletrie

Poitiers, 86000, France

Location

Clinique Mathilde

Rouen, France

Location

CHU Toulouse - Hôpital Pierre Paul Riquet

Toulouse, 31059, France

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: October 4, 2019
• Study Start: November 30, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

FR (16)