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

Wet Macular Degeneration Clinical Trial

— RAINBOW  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279537
• Other study ID #: 17374
• Secondary ID: EY1411FR
• Status: Completed
• Start date: January 2, 2014
• Est. completion date: April 17, 2019

Study information

• Verified date: November 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 593
• Est. completion date: April 17, 2019
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

France, 

References & Publications (1)

Cohen SY, Dominguez M, Coscas F, Faure C, Baillif S, Oubraham H, Kodjikian L, Weber M; RAINBOW study investigators. Final 4-year results of the RAINBOW real-world study: intravitreal aflibercept dosing regimens in France in treatment-naive patients with n — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the measurement of best-corrected visual acuity (BCVA) from baseline to 12 months.	As assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) method or any visual logarithmic scale	Baseline to 12 months
Secondary	Change in Best Corrected Visual Acuity (BCVA) during the second year and until the fourth year of treatment versus the initial visit		Baseline to 2 year, 3 year, 4 year
Secondary	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)		Baseline to 1 year, 2 year, 3 year, 4 year
Secondary	Percentage of patients losing fewer than 15 letters from the initial visit visual acuity at each follow-up visit		Baseline to 1 year, 2 year, 3 year, 4 year

External Links

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