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Clinical trial

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

ID
Name
19140
Description
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 (AMD) in real-life treatment practice The primary objective is: - To collect safety data in wet AMD patients treated with intravitreal aflibercept injection The secondary objective is: - To determine how disease activity is monitored including type and frequency of ocular tests and frequency of injections
Trial arms
Trial start
2019-02-14
Estimated PCD
2022-11-25
Trial end
2023-05-26
Status
Completed
Treatment
Aflibercept (Eylea, BAY86-5321)
Intravitreal Aflibercept as prescribed by the treating Physician
Arms:
Decision to treat with intravitreal aflibercept for wet AMD
Size
100
Primary endpoint
Frequency of reported ocular and non-ocular adverse events during observation period
Up to 6 months
Percentage of reported ocular and non-ocular adverse events during observation period
Up to 6 months
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-06-09

1 organization

1 product

1 indication

Organization
Bayer
Product
Aflibercept
Indication
Age-related Macular Degeneration