check_circleStudy Completed

Wet Age-related Macular Degeneration

Bayer Identifier:

19140

ClinicalTrials.gov Identifier:

NCT03290794

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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 Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
100
Trial Dates
February 2019 - May 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, India

Primary Outcome

  • Frequency of reported ocular and non-ocular adverse events during observation period
    unilateral / bilateral treatment
    date_rangeTime Frame:
    Up to 6 months
  • Percentage of reported ocular and non-ocular adverse events during observation period
    unilateral / bilateral treatment
    date_rangeTime Frame:
    Up to 6 months

Secondary Outcome

  • Type of ocular tests undertaken
    e.g. Visual acuity, ocular computed tomography, indocyanine angiography, Angiography, Fundus photography
    date_rangeTime Frame:
    Up to 6 months
  • Interval between ocular test
    Date of ocular test
    date_rangeTime Frame:
    Up to 6 months
  • Date of aflibercept injections
    Date of aflibercept injections
    date_rangeTime Frame:
    Up to 6 months
  • Injection dose
    Injection dose
    date_rangeTime Frame:
    Up to 6 months
  • Interval (days) between aflibercept injections
    During observation periods
    date_rangeTime Frame:
    Up to 6 months
  • Frequency of monitoring / clinic visits
    Frequency of monitoring / clinic visits
    date_rangeTime Frame:
    Up to 6 months

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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