Fluocinolone acetonide for Diabetic macular oedema

Inclusion criteria

• {"criterion_text":"- Patients who have given their free, informed and written consent"}
• {"criterion_text":"- Patients aged 18 and over"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patient who has had at least one anatomically and functionally effective DXM injection for more than 4 months"}
• {"criterion_text":"- Patient who has had an anti-VEGF injection for more than 3 months"}
• {"criterion_text":"- Pseudophakic patient with surgery more than 6 months ago"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Best Corrected Visual acuity (BCVA) ≤ 80 letters ETDRS"}

Exclusion criteria

• {"criterion_text":"- Person who is not affiliated with the national health insurance system"}
• {"criterion_text":"- In the eye studied : Patients with untreated severe proliferative or non-proliferative diabetic retinopathy"}
• {"criterion_text":"- In the eye studied : Patients who have undergone pan-retinal photocoagulation or focal treatment within the last 3 months"}
• {"criterion_text":"- In the eye studied : Patients with capillary macroaneurysms accessible to focal laser treatment"}
• {"criterion_text":"- In the eye studied : Patients with ocular hypertonia > 21 mmHg despite treatment with more than 2 molecules"}
• {"criterion_text":"- In the eye studied : Aphakic patients or patients with a history of capsular rupture and wearing an iris-fixed or transcleral implant"}
• {"criterion_text":"- In the eye studied : Phakic patients"}
• {"criterion_text":"- Patients who have already participated in the study"}
• {"criterion_text":"- Patient for whom the follow-up required by the protocol is not feasible (moving house, etc.)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Glycated haemoglobin > 12%."}
• {"criterion_text":"- In the eye studied : -\tPatient who received an injection of Iluvien (fluocinolone acetonide) less than 24 months ago"}
• {"criterion_text":"- Person subject to a measure of legal protection or a court order"}
• {"criterion_text":"- Patient unable to give consent"}
• {"criterion_text":"- Patients with a known hypersensitivity to the active substance or to one of the excipients of Ozurdex® or Iluvien®"}
• {"criterion_text":"- Pregnant, parturient or breast-feeding women"}

Primary endpoints

• {"endpoint_text":"- Incremental cost-utility ratio at 3 years, from a societal point of view, expressed in terms of cost per year of life gained in good health (cost/QALY).","definition_or_measurement_approach":"Cost-utility ratio at 3 years from a societal perspective, expressed as cost per QALY (cost per year of life gained in good health)."}

Secondary endpoints

• {"endpoint_text":"- BCVA measured using the ETDRS at each follow-up visit (including inclusion): Construction of the average variation using the AUC approach over the 0-12 month, 0-24 month and 0-36 month periods","definition_or_measurement_approach":"Best corrected visual acuity measured on ETDRS at each visit; average variation constructed by AUC over 0-12, 0-24, 0-36 month periods."}
• {"endpoint_text":"- BCVA measured using the ETDRS at each follow-up visit (including inclusion): Construction of the difference between inclusion and 12, 24 and 36 months","definition_or_measurement_approach":"ETDRS BCVA at visits; difference between baseline and 12, 24, 36 months."}
• {"endpoint_text":"- BCVA measured using the ETDRS at each follow-up visit (including inclusion): Construction of the gain ≥15 letters (yes/no) variable at 12, 24 and 36 months compared with inclusion","definition_or_measurement_approach":"Proportion of patients achieving BCVA gain ≥ 15 ETDRS letters at 12, 24, 36 months vs baseline."}
• {"endpoint_text":"- BCVA measured using the ETDRS at each follow-up visit (including inclusion): Construction of the \"BCVA involvement\" ≥80 letters (yes/no) variable at 12, 24 and 36 months compared with inclusion","definition_or_measurement_approach":"Proportion of patients with BCVA ≥ 80 ETDRS letters at 12, 24, 36 months vs baseline."}
• {"endpoint_text":"- Central retinal thickness, measured as the central foveolar thickness by optical coherence tomography at inclusion, 12, 24, and 36 months: construction of the difference between inclusion and 12, 24 and 36 months","definition_or_measurement_approach":"Central foveolar retinal thickness measured by OCT at baseline, 12, 24, 36 months; differences from baseline computed."}
• {"endpoint_text":"- Treatment regimen (number of injections and time to re-injection)","definition_or_measurement_approach":"Recording number of injections and time-to-reinjection per patient."}
• {"endpoint_text":"- Additional ophthalmological treatments and visits compared with conventional follow-up.","definition_or_measurement_approach":"Comparison of additional ophthalmological procedures and visit frequency versus conventional follow-up."}
• {"endpoint_text":"- VFQ-25 quality of life scores at baseline and at 12, 24 and 36 months","definition_or_measurement_approach":"VFQ-25 QoL questionnaire scores measured at baseline, 12, 24, 36 months."}
• {"endpoint_text":"- Adverse events (ocular hypertonia with initiation of a new treatment or filtering surgery, endophthalmitis, retinal detachment, etc.) at 12, 24 and 36 months.","definition_or_measurement_approach":"Recording occurrence of specified ocular adverse events at 12, 24, 36 months."}
• {"endpoint_text":"- Incremental cost-effectiveness ratio at 3 years expressed in terms of cost per life-year gained, then in terms of cost per case of visual impairment avoided (visual impairment being defined by a result of 4/10ths, i.e. 65 letters ETDRS) and finally in terms of cost per case of legal blindness avoided (blindness being defined by a BCVA ≤ 1/20th, i.e. 20 letters ETDRS)","definition_or_measurement_approach":"Cost-effectiveness at 3 years expressed as cost per life-year gained, cost per case of visual impairment avoided (BCVA 65 letters ETDRS), and cost per case of legal blindness avoided (BCVA ≤ 20 letters ETDRS)."}
• {"endpoint_text":"- Net financial impact of widespread use of the FA implant on the compulsory health insurance budget: costs incurred, costs avoided.","definition_or_measurement_approach":"Budget impact analysis estimating costs incurred and avoided on compulsory health insurance."}

France

Earliest CTIS Part Ii Submission Date

28-05-2024

Latest Decision Or Authorization Date

30-04-2025

Processing Time Days

337

Number Of Sites

12

Number Of Participants

106

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Dijon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France