Real Life of Aflibercept In FraNce: oBservatiOnnal Study in Wet AMD (RAINBOW)

November 3, 2023 updated by: Bayer

A Retrospective and Prospective Non-interventional Open Label Study to Assess the Real Life of Treatment-naive Patients With Wet Age-related Macular Degeneration in Routine Clinical Practice in France and Starting an Anti VEGF Therapy With Aflibercept

The purpose of this study is to collect real-life data on patients with wet age related macular degeneration (AMD) for whom treatment with Eylea was initiated

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is both retrospective and prospective to collect local real life data on patients under routine treatment. The observation period starts on January 2014. Patients who have received the 1st injection with Eylea from January 2014 will be enrolled.

Patients will be followed up for a period of 48 months or until it is no longer possible

Study Type

Observational

Enrollment (Actual)

593

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Multiple Locations, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Naïve treatment patients with wet AMD who started a treatment with Anti VEGF (Vascular Endothelial Growth Factor) may be included in the study

Description

Inclusion Criteria:

  • Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
  • Patient with 1st injection of Eylea from 01 January 2014 until 30 April 2015 will be enrolled
  • Prior/current treatment with any anti-VEGF intravitreal injections or macular laser (laser and/or visudyne/PDT) in the fellow eye is allowed
  • Man or woman aged 18 years or more
  • Patient who has been given appropriate information about the study objectives and procedures and who has given his/her written, informed consent;

Exclusion Criteria:

  • Patient with another retinal disease: diabetic retinopathy, diabetic macular oedema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks
  • Patient who does not meet the local indication criteria for Eylea treatment.Contraindications listed in the Summary of Product Characteristics (SmPC) must be taken into account
  • Patient who has previously been treated with any macular laser (laser and/or visudyne/PDT) or any anti-VEGF intravitreal injections for the study eye
  • Patient taking part in an interventional study at the time of enrolment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
According to the recommendations of the Summary of Product Characteristics (SmPC)
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the measurement of best-corrected visual acuity (BCVA) from baseline to 12 months.
Time Frame: Baseline to 12 months
As assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) method or any visual logarithmic scale
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Best Corrected Visual Acuity (BCVA) during the second year and until the fourth year of treatment versus the initial visit
Time Frame: Baseline to 2 year, 3 year, 4 year
Baseline to 2 year, 3 year, 4 year
Percentage of patients who experienced a gain in BCVA, from initial visit to each follow-up visit (letter score of ≥ 0 letters, ≥ 5 letters, ≥ 10 letters, ≥ 15 letters)
Time Frame: Baseline to 1 year, 2 year, 3 year, 4 year
Baseline to 1 year, 2 year, 3 year, 4 year
Percentage of patients losing fewer than 15 letters from the initial visit visual acuity at each follow-up visit
Time Frame: Baseline to 1 year, 2 year, 3 year, 4 year
Baseline to 1 year, 2 year, 3 year, 4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2014

Primary Completion (Actual)

April 17, 2019

Study Completion (Actual)

April 17, 2019

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimated)

October 31, 2014

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17374
  • EY1411FR (Other Identifier: Company Internal)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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