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

Phase 1

Recruiting

• Conditions: Diabetic Macular Oedema; MedDRA version: 20.1Level: LLTClassification code: 10057915Term: Diabetic macular oedema Class: 10015919; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: CTIS2024-513983-24-00
• Lead Sponsor: Centre Hospitalier Universitaire De Dijon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Patients who have given their free, informed and written consent, Patients aged 18 and over, Patient with DME greater than 300 microns central foveolar thickness still present after at least 2 years of treatment and responsible for a drop in visual activity (reduced visual acuity < 6/10), Patient who has had at least one anatomically and functionally effective DXM injection for more than 5 months, Patient who has had an anti-VEGF injection for more than 3 months, Pseudophakic patient with surgery more than 6 months ago, Patients with uni- or bilateral diabetic macular oedema (in the case of bilateral diabetic macular oedema, the most affected eye will be included in the study)

Exclusion Criteria

Person who is not affiliated with the national health insurance system, In the eye studied : Patients with untreated severe proliferative or non-proliferative diabetic retinopathy, In the eye studied : Patients who have undergone pan-retinal photocoagulation or focal treatment within the last 3 months, In the eye studied : Patients with capillary macroaneurysms accessible to focal laser treatment, In the eye studied : Patients with ocular hypertonia > 21 mmHg despite treatment with more than 2 molecules, In the eye studied : Aphakic patients or patients with a history of capsular rupture and wearing an iris-fixed or transcleral implant, In the eye studied : Phakic patients, Person subject to a measure of legal protection or a court order, Pregnant, parturient or breast-feeding women, Patient unable to give consent, Patients with a known hypersensitivity to the active substance or to one of the excipients of Ozurdex® or Iluvien®, Patients who have already participated in the study, Patient for whom the follow-up required by the protocol is not feasible (moving house, etc.), 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 haemoglobin > 12%.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified