Status:
RECRUITING
Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 te...
Eligibility Criteria
Inclusion
- 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;
- 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).
- 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 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
Exclusion
Key Trial Info
Start Date :
October 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04910503
Start Date
October 29 2021
End Date
April 1 2030
Last Update
May 9 2025
Active Locations (1)
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1
CHU Dijon-Bourgogne
Dijon, France, 21 000