Status:
COMPLETED
Evaluate the Effectiveness of Intravitreal (IVT) Aflibercept Injection in Clinical Practice in naïve Patients With Neovascular Age-related Macular Degeneration (nAMD)
Lead Sponsor:
Bayer
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Brief Summary
There is a need to investigate the effectiveness of IVT aflibercept injection in routine clinical practice. The aim of this study is to collect 12-month real-world clinical data from treatment-naïve ...
Eligibility Criteria
Inclusion
- Adult patient aged 50 years or more at aflibercept treatment initiation.
- Treatment-naïve patients with nAMD
- Patients who initated treatment with IVT aflibercept injection between 1st April 2014 to 31st May 2016
- Patients that have been decided to be treated with IVT aflibercept with a minimum treatment follow-up with IVT aflibercept injection of at least 12-months, in accordance with the approved SmPC.
- Patients who have been provided with appropriate information about the study objectives and procedures and who have given their written informed consent.
Exclusion
- Patients who have previously been treated with anti-VEGF intravitreal injections, systemic anti-VEGF or pro-VEGF treatments, as well as other intravitreal steroids or steroid implants for the study eye.
- Patients that switched to another treatment alternative different from IVT aflibercept injection during observation period of 12 months
- Patients with another retinal disease: diabetic retinopathy, diabetic macular edema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks.
- Patients with scarring, fibrosis, or atrophy involving the center of the fovea in the study eye at treatment initiation
- Patients with advanced cataract or advanced glaucoma
- Patients with presence of retinal pigment epithelial tears or rips involving the macula in the study eye prior to treatment initiation.
- Patients who do not meet the local Guideline criteria for aflibercept treatment. Contraindications listed in the SmPC must be taken into account.
Key Trial Info
Start Date :
February 28 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03411941
Start Date
February 28 2018
End Date
March 1 2019
Last Update
December 5 2019
Active Locations (1)
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1
Many locations
Multiple Locations, Spain