Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT04910503
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;
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04910503
Study Brief:
Protocol Section:
NCT04910503