Comparing two eye implants for treating resistant diabetic macular edema
Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
This study tests which of two eye implants can help people with stubborn diabetic macular edema see better and improve their eye health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Trial ID | NCT04910503 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with treated DME greater than 300 microns in central foveolar thickness who have not responded to previous treatments.
Not a fit: Patients who are not covered by national health insurance or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with resistant diabetic macular edema, potentially improving their vision and quality of life.
How similar studies have performed: Other studies have shown varying degrees of success with corticosteroid implants for DME, but this specific comparison of Fluocinolone Acetonide and Dexamethasone is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dijon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.