Age-related Macular Degeneration (AMD)MEDIALNCT03577041
Medico-economic Evaluation of Anti-VEGF Treatments in the Treatment of naïve Age-related Macular Degeneration (AMD): a Model Adapted to the French Context
An observational study of Age-related Macular Degeneration (AMD), run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Age-related Macular Degeneration (AMD)
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2020to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 50 years of age with a naive neovascular AMD form with a retro-fleeal, unilateral or bilateral location, to be treated with intravitreous injections of Bevacizumab or Ranibizumab or Aflibercept according to the practice of each service
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Sophie BRYSELBOUT, MD, 03 22 08 92 19, bryselbout.sophie@chu-amiens.fr
About this study
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.
Read the 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.
- Conditions
- Age-related Macular Degeneration (AMD)
- Keywords
- Neovascular Age-Related Macular Degeneration, Bevacizumab, Cost-Effective, Quality of life
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-utility analysis of the modalities of management of neovascular age-related macular degeneration
Using a probabilistic Markov model
Measured: 12 months
Secondary outcomes (2)
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)
Measured: 12 months
Quality of life coefficient: HUI 3 questionnaire
Quality of life will be estimated using the HUI 3 questionnaire and corresponding value-set
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start29 Jan 2020
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie BRYSELBOUT, Dr, Study director, CHU AmiensMarc MURAINE, Pr, Principal investigator, CHU RouenXavier ZANLONGHI, Dr, Principal investigator, Nantes University HospitalCarl ARNDT, Principal investigator, Carl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577041
- Sponsor's protocol ID
- PI2017_843_0009
- Acronym
- MEDIAL
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2018
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03577041
- Acronym / sponsor ID
- MEDIAL / PI2017_843_0009
- Conditions
- Age-related Macular Degeneration (AMD)
- Keywords
- Neovascular Age-Related Macular Degeneration, Bevacizumab, Cost-Effective, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 50 years of age with a naive neovascular AMD form with a retro-fleeal, unilateral or bilateral location, to be treated with intravitreous injections of Bevacizumab or Ranibizumab or Aflibercept according to the practice of each service
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cost-utility analysis of the modalities of management of neovascular age-related macular degeneration
Time frame: 12 months
Using a probabilistic Markov model
2 secondary outcomes
Micro-costing type evaluation of packaging of Intravitreal injections of Bevacizumab in pharmacy hospital.
Time frame: 12 months
Quality of life coefficient: HUI 3 questionnaire
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie BRYSELBOUT, Dr study director
CHU Amiens
Marc MURAINE, Pr principal investigator
CHU Rouen
Xavier ZANLONGHI, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Macular Degeneration (AMD), run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie BRYSELBOUT, Dr (33 3 22 08 92 19, bryselbout.sophie@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-utility analysis of the modalities of management of neovascular age-related macular degeneration (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.