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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279537
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Brief Summary:
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

Condition or disease Intervention/treatment
Wet Macular Degeneration Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

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

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Study Type : Observational
Actual Enrollment : 593 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: 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
Actual Study Start Date : January 2, 2014
Actual Primary Completion Date : April 17, 2019
Actual Study Completion Date : April 17, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279537


Locations
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France
Multiple Locations, France
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02279537    
Other Study ID Numbers: 17374
EY1411FR ( Other Identifier: Company Internal )
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Wet age-related macular Degeneration (Wet-AMD)
Naïve patients
Real life
Aflibercept
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases