- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577041
Medico-economic Evaluation of Anti-VEGF Treatments in the Treatment of naïve Age-related Macular Degeneration (AMD): a Model Adapted to the French Context (MEDIAL)
Study Overview
Status
Conditions
Detailed Description
Numerous clinical trials have shown the effectiveness of Bevacizumab in the treatment of neovascular AMD as well that non-inferiority compared to Ranibizumab in terms of clinical efficacy at 1 year on visual acuity measured by the ETDRS scale of patients with neovascular AMD.
Regarding general tolerance, a recent meta-analysis including a large number of patients did not find any difference in systemic serious adverse reactions, neither any new special signal of tolerance with Bevacizumab. Concerning eye tolerance, there is no evidence of difference significant. Medico-economic analyzes carried out in other countries, as the United States or Brazil, have shown that Bevacizumab is cost-effective compared to Ranibizumab in AMD Neovascular.
The cost-utility analysis of the different methods of care patients with AMD will rely on the construction of a self-centered model built from: data available in natural history literature AMD in the absence of treatment; results of the network meta-analysis comparing effectiveness and tolerance of different strategies to assess; available data on adherence and persistence of treatments; pharmacovigilance data on the occurrence of side effects.
This analysis benefits from two related studies:
- Micro-costing, multicenter study of the preparation of intravitreal injections of Bevacizumab hospital pharmacy.
- Multicenter, prospective evaluation, cross-section, quality of life data and patient cost depending on the level of visual acuity.
According to the recommendations, at the beginning of the treatment, after the diagnosis of neovascular naive AMD, the patient will benefit from a fixed regimen of treatment by intravitreous injection of Bevacizumab or Ranibizumab or Aflibercept renewed every month for 3 months. Before each Intra-vitreous injection, the patient will be reviewed in consultation to collect the occurrence of events adverse reactions related to the injection of one of the three products. After 3 months, the monthly intra-vitreous injections will be left to the appreciation of the investigator.
The follow-up of the patients, during a specialized consultation will be spread out over 6 months according to the rhythm of a consultation by months and then 12 months.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sophie BRYSELBOUT, Dr
- Phone Number: 33 3 22 08 92 19
- Email: bryselbout.sophie@chu-amiens.fr
Study Locations
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Amiens, France, 80480
- Recruiting
- CHU Amiens
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Naive neovascular AMD form of retro localization foveal, unilateral or bilateral (one eye per patient will be studied),
- Patients to be treated with intravitreous injections of Bevacizumab or Ranibizumab or Aflibercept,
- Patient using effective contraception if he is of childbearing age
- Patient informed and not having made his opposition to the research,
- Patient under social security scheme.
Exclusion Criteria:
- Previous or current treatment of AMD by intravenous injection of anti-VEGF or surgery dating less than 2 months in the studied eye,
- Contraindications to the taking of Bevacizumab or Ranibizumab or Aflibercept,
- Aphakia in the studied eye,
- Fibrosis or retrofoveolar retinal atrophy of the eye studied,
- Tearing of the pigment epithelium reaching my macula of the studied eye,
- Choroidal neovascularization unrelated to AMD,
- Diabetic retinopathy and / or diabetic maculopathy proven,
- Glycated hemoglobin greater than 12%,
- Known hypersensitivity to pharmaceutical agents used,
- Pregnant or lactating women,
- Severe active intraocular inflammation, or history autoimmune or idiopathic uveitis,
- Active or suspected ocular or periocular infection,
- Intraocular pressure> 25mmHg despite two hypotonizing treatments in eye drops,
- Patient under tutorship or curatorship or private public law.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-utility analysis of the modalities of management of neovascular age-related macular degeneration
Time Frame: 12 months
|
Using a probabilistic Markov model
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Micro-costing type evaluation of packaging of Intravitreal injections of Bevacizumab in pharmacy hospital.
Time Frame: 12 months
|
Costs of packaging of Intravitreal injections of Bevacizumab in pharmacy hospital (flasks of Bevacizumab, materials, personal, infrastructure, conservation)
|
12 months
|
Quality of life coefficient: HUI 3 questionnaire
Time Frame: 12 months
|
Quality of life will be estimated using the HUI 3 questionnaire and corresponding value-set
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marc MURAINE, Pr, CHU Rouen
- Principal Investigator: Xavier ZANLONGHI, Dr, CHU Nantes
- Principal Investigator: Carl ARNDT, Carl
- Study Director: Sophie BRYSELBOUT, Dr, CHU Amiens
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2017_843_0009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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