Status:
COMPLETED
Structured Post-marketing Surveillance to Collect the Safety Data of Intravitreal Aflibercept Injection (IVT-AFL) in Patients of Wet Age-related Macular Degeneration During Real World Clinical Practice
Lead Sponsor:
Bayer
Conditions:
Wet Age-related Macular Degeneration
Eligibility:
All Genders
18+ years
Brief Summary
The proposed regulatory post-marketing surveillance (PMS) study will be planned to collect the safety data of aflibercept intravitreal injection in patients with wet Age-related Macular Degeneration (...
Detailed Description
The study will be multicenter, observational, prospective, single arm, post marketing surveillance study of intravitreal aflibercept injection in wet AMD patients in routine clinical practice and real...
Eligibility Criteria
Inclusion
- Decision to treat with intravitreal aflibercept injection prior to patient enrolment as per the treating ophthalmologist's routine clinical practice.
- Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities (DCGI) for use with intravitreal aflibercept injection.
- Patient or legal delegate signed informed consent.
Exclusion
- Participation in a clinical trial of an investigational agent within 30 days.
- Patients receiving other anti-VEGF agent in fellow eye.
- Contraindications according to the local prescribing information.
Key Trial Info
Start Date :
February 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 26 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03290794
Start Date
February 14 2019
End Date
May 26 2023
Last Update
June 9 2023
Active Locations (1)
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1
Many Locations
Multiple Locations, India