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

Sponsor
Bayer
Study ID
NCT03290794
Status
Completed

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Feb 14, 2019
Status verified
Jun 2023
Primary completion
Nov 25, 2022
Completion
May 26, 2023

Study Design

Enrollment
100 participants (actual)

Arms

  • Arm: Decision to treat with intravitreal aflibercept for wet AMD
    Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities for use with intravitreal aflibercept.

Primary Outcome Measure

Frequency of reported ocular and non-ocular adverse events during observation period [ Time Frame: Up to 6 months ]

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