Age-related Macular Degeneration (AMD) Clinical Trial
— MEDIALOfficial title:
Medico-economic Evaluation of Anti-VEGF Treatments in the Treatment of naïve Age-related Macular Degeneration (AMD): a Model Adapted to the French Context
NCT number | NCT03577041 |
Other study ID # | PI2017_843_0009 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2019 |
Est. completion date | July 1, 2023 |
Age-related macular degeneration (AMD) is the leading cause of blindness after 50 years in industrialized countries, compromising daily activities and reducing quality of life. And whose treatment is one of the first health expenditures. Since September 2015, Bevacizumab, which does not have marketing authorization in AMD, has been given a temporary recommendation for use. Studies in other countries have shown that bevacizumab is cost-effective in the treatment of AMD compared to other anti-VEGF therapies used.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cost-utility analysis of the modalities of management of neovascular age-related macular degeneration | Using a probabilistic Markov model | 12 months | |
Secondary | Micro-costing type evaluation of packaging of Intravitreal injections of Bevacizumab in pharmacy hospital. | Costs of packaging of Intravitreal injections of Bevacizumab in pharmacy hospital (flasks of Bevacizumab, materials, personal, infrastructure, conservation) | 12 months | |
Secondary | Quality of life coefficient: HUI 3 questionnaire | Quality of life will be estimated using the HUI 3 questionnaire and corresponding value-set | 12 months |
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