Cost-effectiveness of anti-VEGF treatments for newly diagnosed AMD in France

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study builds a medico-economic model using data from AMD patients who have not yet received anti-VEGF therapy. It combines natural history data, network meta-analysis results for effectiveness and safety, adherence information, and pharmacovigilance to compare costs and outcomes of different anti-VEGF options. It also includes micro-costing of injection preparation and a multicenter evaluation of quality of life and patient costs by vision level. The analysis is tailored to the French healthcare context and social security system.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU Amiens
  Amiens, France Recruiting

Study contacts

• Principal investigator: Marc MURAINE, Pr — CHU Rouen
• Study coordinator: Sophie BRYSELBOUT, Dr
• Email: bryselbout.sophie@chu-amiens.fr
• Phone: 33 3 22 08 92 19

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.