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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Dijon

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

29 Oct 2021 → ongoing

Decision date (initial)

2024-07-09

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513983-24-00

EudraCT number

2020-005100-18

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacoeconomic

To assess the cost-utility ratio at 3 years of treatment with fluocinolone acetonide (FA) intravitreal implant compared with treatment with dexamethasone (DXM) intravitreal implant in the treatment of resistant DME in pseudophakic patients, from a societal point of view

Secondary objectives 9

1. Compare the effectiveness of treatments in terms of : Mean change in best corrected visual acuity (BCVA): over the periods 0-12 months, 0-24 months and 0-36 months, and at 12, 24 and 36 months from inclusion
2. Compare the effectiveness of treatments in terms of : Rate of patients with an improvement in BCVA ≥ 15 letters at 12, 24 and 36 months compared with inclusion
3. Compare the effectiveness of treatments in terms of: Rate of patients with at least 80 letters of BCVA at 12, 24 and 36 months compared with inclusion
4. Compare the effectiveness of treatments in terms of: Mean change in central foveolar retinal thickness at 12, 24 and 36 months from baseline
5. Compare the effectiveness of treatments in terms of: Treatment regimen and additional treatments
6. To compare the effect of treatments on quality of life at baseline, 12, 24 and 36 months
7. To compare the safety of treatments in terms of the occurrence of adverse events at 12, 24 and 36 months
8. To assess the cost-effectiveness impact over 3 years of treatment with FA implants compared with DXM implants from a societal point of view
9. Evaluate the budgetary impact over 5 years of generalising FA treatment in France on the compulsory health insurance budget

Conditions and MedDRA coding

Diabetic Macular Oedema

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Patients who have given their free, informed and written consent
2. Patients aged 18 and over
3. 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
4. Patient who has had at least one anatomically and functionally effective DXM injection for more than 4 months
5. Patient who has had an anti-VEGF injection for more than 3 months
6. Pseudophakic patient with surgery more than 6 months ago
7. 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)
8. Best Corrected Visual acuity (BCVA) ≤ 80 letters ETDRS

Exclusion criteria 16

1. Person who is not affiliated with the national health insurance system
2. In the eye studied : Patients with untreated severe proliferative or non-proliferative diabetic retinopathy
3. In the eye studied : Patients who have undergone pan-retinal photocoagulation or focal treatment within the last 3 months
4. In the eye studied : Patients with capillary macroaneurysms accessible to focal laser treatment
5. In the eye studied : Patients with ocular hypertonia > 21 mmHg despite treatment with more than 2 molecules
6. In the eye studied : Aphakic patients or patients with a history of capsular rupture and wearing an iris-fixed or transcleral implant
7. In the eye studied : Phakic patients
8. Person subject to a measure of legal protection or a court order
9. Pregnant, parturient or breast-feeding women
10. Patient unable to give consent
11. Patients with a known hypersensitivity to the active substance or to one of the excipients of Ozurdex® or Iluvien®
12. Patients who have already participated in the study
13. Patient for whom the follow-up required by the protocol is not feasible (moving house, etc.)
14. 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
15. Glycated haemoglobin > 12%.
16. In the eye studied : - Patient who received an injection of Iluvien (fluocinolone acetonide) less than 24 months ago

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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).

Secondary endpoints 11

1. 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
2. BCVA measured using the ETDRS at each follow-up visit (including inclusion): Construction of the difference between inclusion and 12, 24 and 36 months
3. 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
4. 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
5. 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
6. Treatment regimen (number of injections and time to re-injection)
7. Additional ophthalmological treatments and visits compared with conventional follow-up.
8. VFQ-25 quality of life scores at baseline and at 12, 24 and 36 months
9. Adverse events (ocular hypertonia with initiation of a new treatment or filtering surgery, endophthalmitis, retinal detachment, etc.) at 12, 24 and 36 months.
10. 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)
11. Net financial impact of widespread use of the FA implant on the compulsory health insurance budget: costs incurred, costs avoided.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Dijon

Sponsor organisation

Centre Hospitalier Universitaire De Dijon

Address

2 Boulevard Mal De Lattre De Tassigny

City

Dijon

Postcode

21000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Dijon

Contact name

Chef de Projets Recherche

Public contact point

Organisation

Centre Hospitalier Universitaire De Dijon

Contact name

Chef de Projets Recherche

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications