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

Study acronym: EMMA
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Eligibility criteria expanded, about 17 wordsv8 See this version in full on ClinicalTrials.gov ↗
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Notable Primary and study completion dates: Apr 1, 2027 to Apr 2030v6
  4. Minor Eligibility criteria revisedv5 See this version in full on ClinicalTrials.gov ↗
  5. Minor Eligibility criteria expanded, about 3 wordsv4 See this version in full on ClinicalTrials.gov ↗
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  1. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 1, 2021 to Oct 29, 2021 · Primary and study completion dates: Jan 1, 2027 to Apr 1, 2027 · Site details revisedv3 Show 3 more changesShow less
    • Start date changed from estimate of Jul 1, 2021 to Oct 29, 2021
    • Primary and study completion dates: Jan 1, 2027 to Apr 1, 2027
    • Site details revised
  2. Notable Start date: Jun 1, 2021 to Jul 1, 2021 Primary and study completion dates: Dec 1, 2026 to Jan 1, 2027 · Eligibility criteria shortened, about 8 wordsv2 Show 2 more changesShow less
    • Primary and study completion dates: Dec 1, 2026 to Jan 1, 2027
    • Eligibility criteria shortened, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04910503
Lead Sponsor Centre Hospitalier Universitaire Dijon
Conditions Diabetic Macular Edema
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov