Comparing two eye implants for treating resistant diabetic macular edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of two different intravitreal implants, Fluocinolone Acetonide and Dexamethasone, in patients suffering from resistant diabetic macular edema (DME). The study focuses on patients who have not responded adequately to previous treatments and have significant visual impairment due to DME. Participants will receive one of the two implants to assess improvements in visual acuity and retinal thickness over time. The trial aims to determine which implant offers better outcomes for patients with this challenging condition.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Dijon-Bourgogne
  Dijon, France Recruiting

Study contacts

• Study coordinator: Catherine CREUZOT-GARCHER
• Email: catherine.creuzot-garcher@chu-dijon.fr
• Phone: 03.80.29.51.73

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.