Trial Condition(s):

Wet age-related macular degeneration

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

Bayer Identifier:

19140

ClinicalTrials.gov Identifier:

NCT03290794

EudraCT Number:

Not Available

Recruitment Complete

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

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.

Trial Summary

Enrollment Goal
100
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, India

Status
Active, not recruiting
 

Trial Design