Trial Condition(s):
Wet Macular Degeneration
Real Life of Aflibercept In FraNce: oBservatiOnnal study in Wet AMD (RAINBOW)
Bayer Identifier:
17374
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, France | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 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 scaleTimeframe: Baseline to 12 months
Secondary Outcome
- Change in Best Corrected Visual Acuity (BCVA) during the second year and until the fourth year of treatment versus the initial visitTimeframe: 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)Timeframe: 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 visitTimeframe: Baseline to 1 year, 2 year, 3 year, 4 year
Additional Information
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