LOADEX: PILOT AND PHASE 2 STUDY OF THE EFFICACY OF A TREATMENT PROTOCOL WITH DEXAMETHASONE IMPLANT LOADING DOSE IN PATIENTS WITH DIABETIC MACULAR EDEMA

Hospices Civils De Lyon16 sites in 1 country100 target enrollmentNovember 30, 2020

DrugsOZURDEX 700 micrograms intravitreal implant in applicator

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Hospices Civils De Lyon
Enrollment: 100
Locations: 16
Primary Endpoint: Difference between the highest value of Best Corrected Visual Acuity (BCVA) observed during follow-up to 52 weeks and the BCVA observed at inclusion (best observed improvement). Corrected visual acuity will be measured as the number of letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale at an initial distance of 4 meters.
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To describe the efficacy at 1 year (52 weeks) of a new Ozurdex® intravitreal implant treatment regimen, in terms of visual acuity, in patients with diabetic macular oedema.

Registry

euclinicaltrials.eu

Start Date

November 30, 2020

End Date

December 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Investigators

Sponsor

Hospices Civils De Lyon

Responsible Party

Principal Investigator

Laurent Kodjikian

Scientific

Hospices Civils De Lyon

Eligibility Criteria

Inclusion Criteria

•Patient over 40 years old
•Patient willing and able to return for all study clinical visits and to complete all related procedures.
•Patient with significant diabetic macular oedema (DMO): * a central macular thickness (CMT) ≥ 285 μm measured by Spectralis/Topcon SD-OCT (spectral-domain optical coherence tomography), or a CMT ≥ 275 μm measured by Cirrus SD-OCT. * visual acuity between 20/32 and 20/230 (between 23 and 78 letters) measured using the ETDRS scale and complying with the measurement protocol at a distance of 4 metres.
•Patient for which it has been decided to insert an intra-retinal dexamethasone implant
•eye naive to any drug treatment (no previous intravitreal corticosteroid or anti-VEGF treatment)
•patient pseudophakic for at least 3 months
•HBA1c < 10%
•blood pressure <160/95 mmHg
•Patient who have given their free, informed and signed consent
•Patient affiliated to a social security scheme or equivalent

Exclusion Criteria

•Study eye aphakic with missing posterior lens capsule
•Last session of focal laser treatment of the posterior pole of the study eye < 1 month
•Vitreo-macular traction syndrome associated with an epiretinal membrane in the study eye
•History of laser treatment in the macular grid of the study eye
•Ocular hypertension or open-angle glaucoma of the studied eye treated with at least one dual therapy.
•Patients with systemic pathology likely to interfere with the evolution of DME and treated with immunosuppressants, systemic corticoids, anti-aldosterone, systemic anti-VEGF, etc.
•Patients undergoing systemic treatment with a toxic effect on the retina or optic nerve: deferoxamine, chloroquine /hydroxychloroquine, tamoxifen and ethambutol; currently or in the 6 months prior to inclusion.
•Known hypersensitivity to the active substance or to one of the excipients or to anesthetic or hypotonizing eye drops.
•History of any pathology, metabolic disease, or any serious suspicion of disease on clinical or laboratory examination, which would contraindicate the use of the dexamethasone intraretinal implant, could affect the interpretation of study results or entail significant risks of complication for the subject.
•Active or suspected infectious conjunctivitis and/or adnexal infection

Outcomes

Primary Outcomes

Difference between the highest value of Best Corrected Visual Acuity (BCVA) observed during follow-up to 52 weeks and the BCVA observed at inclusion (best observed improvement). Corrected visual acuity will be measured as the number of letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale at an initial distance of 4 meters.

Secondary Outcomes

Describe the time required to reach the highest MAVC value during the first 52 weeks, as well as the number of injections.
Description of VA by : oDifference between the highest value of BCVA observed up to M18 and up to M24 and the value at inclusion. Corrected VA measured on the ETDRS scale; o VA value at each visit (monthly for the 1st year) and area under the curve between inclusion and S52 and between inclusion and M24; o At S12,S24,S36,S52,M18 and M24, as well as for the highest CVAM observed in 52 weeks: proportion of patients by CVAM change category (cf protocole)
Total number of injections performed per patient at S52 and M24.
Patient discomfort related to the intravitreal implant, measured by a visual analog scale (VAS between 0 and 10) at each visit between S0 and S52.
At S12,S24,S36,S52,M18 and M24; as well as for the visit at which the best improvement over 52 weeks is observed: Variation in CMT and central foveolar thickness and qualitative analysis of each OCT (from a central section of the fovea: presence of interruptions of the ellipsoid, outer limiting membrane, intraretinal cysts or logettes, presence of disorganized inner retinal layers, subretinal fluid, foveolar depression, epiretinal membrane, vitreo-macular traction and macular exudates).
Proportion of patients with resolution of macular oedema (defined as absence of intraretinal fluid 6 months or more after the last injection) at S52 and M24.
At S12, S24, S36, S52, M18 and M24, the number and percentage of patients with each grade of diabetic retinopathy according to the Staging DRSS will be calculated: improvement (gain of 2 levels or gain of 3 levels), no change, or worsening (loss of 2 levels or loss of 3 levels); between inclusion and S12, S24, S36, S52, M18 and M24, according to a centralised review on colour fundus photographs including at least the 7 ETDRS fields i.e. 30 degrees.
At S12, S24, S36, S52, M18 and M24: qualitative and quantitative analysis of diabetic vascularisation and non-perfusion zones on OCT-angiography (size of capillary non-perfusion zones, size of central avascular zone, presence of macular ischaemia) according to a centralised reading
At each visit: condition of lens implant and posterior chamber determined by biomicroscopy with fundus.
Change in intraocular pressure between inclusion and S52, and between inclusion and M24, and proportion of patients using hypotonising therapy for 24 months.
Adverse events observed throughout the study: o Frequency of ocular prognostic adverse events: see protocol o Incidence of non-ocular life-threatening adverse events: see protocol o Incidence of systemic adverse events: see protocol