NCT03577041

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 22, 2023

Status Verified

February 1, 2023

Enrollment Period

4.3 years

First QC Date

June 4, 2018

Last Update Submit

March 21, 2023

Conditions

Age-related Macular Degeneration (AMD)

Keywords

Neovascular Age-Related Macular DegenerationBevacizumabCost-EffectiveQuality of life

Outcome Measures

Primary Outcomes (1)

  • Cost-utility analysis of the modalities of management of neovascular age-related macular degeneration

    Using a probabilistic Markov model

    12 months

Secondary Outcomes (2)

  • Micro-costing type evaluation of packaging of Intravitreal injections of Bevacizumab in pharmacy hospital.

    12 months

  • Quality of life coefficient: HUI 3 questionnaire

    12 months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Sophie BRYSELBOUT, Dr

    CHU Amiens

    STUDY DIRECTOR

  • Marc MURAINE, Pr

    CHU Rouen

    PRINCIPAL INVESTIGATOR

  • Xavier ZANLONGHI, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

  • Carl ARNDT

    Carl

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie BRYSELBOUT, Dr

CONTACT

33 3 22 08 92 19bryselbout.sophie@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2018

First Posted

July 5, 2018

Study Start

March 1, 2019

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

March 22, 2023

Record last verified: 2023-02

Locations

FR(1)