Diabetic Macular EdemaPhase 4EMMANCT04910503
Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
A Phase 4 study testing Dexamethasone intravitreal implant and Fluocinolone Acetonide Intravitreal Implant in people with Diabetic Macular Edema, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Dexamethasone intravitreal implant and Fluocinolone Acetonide Intravitreal Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 29 Oct 2021to Apr 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Best corrected Visual acuity (BCVA) ≤ 80 letters ETDRS
- 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).
Who cannot join
- 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)
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- 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 who received an injection of Iluvien (fluocinolone acetonide) less than 24 months ago-
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon-Bourgogne
Dijon, 21 000
Catherine CREUZOT-GARCHER, 03.80.29.51.73, catherine.creuzot-garcher@chu-dijon.fr
About this study
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.
Read more
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.
- Conditions
- Diabetic Macular Edema
- Being tested
- Dexamethasone intravitreal implant, Fluocinolone Acetonide Intravitreal Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone intravitreal implantDrug
Implant every 4 months if necessary
Fluocinolone Acetonide Intravitreal ImplantDrug
Implantation
| Study group | Role | What they receive |
|---|---|---|
| Usual strategy | Active comparator | Not described Receives: Drug: Dexamethasone intravitreal implant |
| Innovative strategy | Experimental | Not described Receives: Drug: Fluocinolone Acetonide Intravitreal Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost per healthy year gained
Measured: 3 years after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start29 Oct 2021
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910503
- Sponsor's protocol ID
- CREUZOT PRME 2019
- Acronym
- EMMA
- Status last verified
- May 2025
- First submitted
- 27 May 2021
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
- ClinicalTrials.gov ID
- NCT04910503
- Acronym / sponsor ID
- EMMA / CREUZOT PRME 2019
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual strategy | Active comparator | Drug: Dexamethasone intravitreal implant |
| Innovative strategy | Experimental | Drug: Fluocinolone Acetonide Intravitreal Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
- Best corrected Visual acuity (BCVA) ≤ 80 letters ETDRS
- Patient who has received at least one anatomically and functionally effective dexamethasone (DXM) injection more than 5 months ago
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone intravitreal implantImplant every 4 months if necessary | Drug | Usual strategy |
| Fluocinolone Acetonide Intravitreal ImplantImplantation | Drug | Innovative strategy |
Primary outcome
Cost per healthy year gained
Time frame: 3 years after starting treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone intravitreal implant and Fluocinolone Acetonide Intravitreal Implant in people with Diabetic Macular Edema, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine CREUZOT-GARCHER (03.80.29.51.73, catherine.creuzot-garcher@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost per healthy year gained (time frame: 3 years after starting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.