Back to results

Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema (EMMA)

Primary Purpose

Diabetic Macular Edema

Status

Recruiting

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Dexamethasone intravitreal implant

Fluocinolone Acetonide Intravitreal Implant

About this trial

This is an interventional other trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria*:

Patient who has given free, written and informed consent;
Major patient ;
Patient with treated DME greater than 300 microns of central foveolar thickness still present after at least 2 years of treatment and responsible for a decrease in visual activity (BAV, Boath Audio Visual < 6/10);
Patient who has received at least one anatomically and functionally effective dexamethasone (DXM) injection more than 5 months ago
Patient who has received one anti-VEGF injection more than 3 months ago
Pseudophakic patient with surgery older than 6 months.
Patient with uni or bilateral diabetic macular oedema (in the case of bilateral diabetic macular oedema, the most affected eye will be treated).

Exclusion criteria*:

Patient not covered by national health insurance;
Patient under a measure of legal protection;
Pregnant, parturient or breast-feeding woman;
Patient of full age who is unable to give consent;
Patient who has already participated in the study
Patient for whom the follow-up imposed by the protocol is not feasible (relocation)
Patients with a known hypersensitivity to the active substance or to one of the excipients of Ozurdex®, Iluvien® ; Patients with uveitis or a severe form of asthma
Patients with pre-existing uveitis or glaucoma or active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and mycoses
Glycated hemoglobin > 12%.
In the study eye:
Patient with untreated severe proliferative or non-proliferative diabetic retinopathy;
Patient with pan-retinal photocoagulation or focal treatment less than 3 months old;
Patient with capillary macro aneurysms accessible to focal laser
Patient with ocular hypertonia > 21 mmHg despite a treatment of more than 2 molecules;
Aphakic patients or patients with a history of capsule rupture and iridal or transcleral fixation implants
Phakic patient

Sites / Locations

CHU Dijon-BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual strategy

Innovative strategy

Arm Description

Outcomes

Primary Outcome Measures

Cost per healthy year gained

Secondary Outcome Measures

Full Information

NCT ID

NCT04910503

First Posted

May 27, 2021

Last Updated

August 29, 2022

Sponsor

Centre Hospitalier Universitaire Dijon

1. Study Identification

Unique Protocol Identification Number

NCT04910503

Brief Title

Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema

Acronym

EMMA

Official Title

Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 29, 2021 (Actual)

Primary Completion Date

April 1, 2027 (Anticipated)

Study Completion Date

April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Diabetic macular oedema (DME) is the main cause of visual impairment (or visual acuity) in patients with diabetic retinopathy, as it leads to progressive thickening of the retina, which in the long term leads to progressive death of the photoreceptor cells. It is therefore important to continue to treat macular oedema that has been progressing for several months or even years (resistant DME). The management of DME necessarily involves controlling diabetes (improving glycated haemoglobin levels) and blood pressure, but this is often not enough. Thus, when DME is significant and leads to a decrease in visual acuity, treatments are administered directly into the eye (intravitreal injections). For some years now, corticosteroids have been injected into the vitreous body (the gel that fills the eyeball) through the white of the eye for their anti-inflammatory properties. Indeed, these drugs improve the permeability of the retinal vessels and thus reduce oedema. These intravitreal implants are most often used in patients who have already undergone cataract surgery (pseudophakic) because corticosteroids also tend to aggravate a cataract. Currently, there are two implants containing corticosteroids that can be injected: the dexamethasone implant and the fluocinolone acetonide implant. These two implants have different properties, particularly with regard to their duration of action. Today, the overall management at 3 years and the quality of life associated with the treatments deserve to be evaluated. This study is the first multicenter controlled trial comparing the two reference corticosteroid treatments in terms of overall cost of treatment and follow-up and patient quality of life, while considering their efficacy and side effects. This evaluation will make it possible to precisely define the respective place of each implant in the management of resistant DME.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Usual strategy

Arm Type

Active Comparator

Arm Title

Innovative strategy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Dexamethasone intravitreal implant

Intervention Description

Implant every 4 months if necessary

Intervention Type

Drug

Intervention Name(s)

Fluocinolone Acetonide Intravitreal Implant

Intervention Description

Implantation

Primary Outcome Measure Information:

Title

Cost per healthy year gained

Time Frame

3 years after starting treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria*: Patient who has given free, written and informed consent; Major patient ; Patient with treated DME greater than 300 microns of central foveolar thickness still present after at least 2 years of treatment and responsible for a decrease in visual activity (BAV, Boath Audio Visual < 6/10); Patient who has received at least one anatomically and functionally effective dexamethasone (DXM) injection more than 5 months ago Patient who has received one anti-VEGF injection more than 3 months ago Pseudophakic patient with surgery older than 6 months. Patient with uni or bilateral diabetic macular oedema (in the case of bilateral diabetic macular oedema, the most affected eye will be treated). Exclusion criteria*: Patient not covered by national health insurance; Patient under a measure of legal protection; Pregnant, parturient or breast-feeding woman; Patient of full age who is unable to give consent; Patient who has already participated in the study Patient for whom the follow-up imposed by the protocol is not feasible (relocation) Patients with a known hypersensitivity to the active substance or to one of the excipients of Ozurdex®, Iluvien® ; Patients with uveitis or a severe form of asthma Patients with pre-existing uveitis or glaucoma or active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and mycoses Glycated hemoglobin > 12%. In the study eye: Patient with untreated severe proliferative or non-proliferative diabetic retinopathy; Patient with pan-retinal photocoagulation or focal treatment less than 3 months old; Patient with capillary macro aneurysms accessible to focal laser Patient with ocular hypertonia > 21 mmHg despite a treatment of more than 2 molecules; Aphakic patients or patients with a history of capsule rupture and iridal or transcleral fixation implants Phakic patient

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Catherine CREUZOT-GARCHER

Phone

03.80.29.51.73

catherine.creuzot-garcher@chu-dijon.fr

Facility Information:

Facility Name

CHU Dijon-Bourgogne

City

Dijon

ZIP/Postal Code

21 000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Catherine CREUZOT-GARCHER

Phone

03.80.29.51.73

catherine.creuzot-garcher@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema

We'll reach out to this number within 24 hrs