Trial Condition(s):

Wet age-related macular degeneration

Assessment of proactive treatments in patients with wet age-related macular Degeneration (wAMD) which have never undergone treatment of this particular disease (XTEND)

Bayer Identifier:

20359

ClinicalTrials.gov Identifier:

NCT03939767

EudraCT Number:

Not Available

Recruitment Complete

Trial Purpose

In this observational study researchers want to learn more about changes in visual acuity (clarity of vision) with proactive flexible treatments over time in patients suffering from wet age-related macular degeneration (wAMD) after decision to treat with Aflibercept (Eylea) was made. Wet AMD is an eye disease that progressively destroys the macula, the central portion of the retina, impairing central vision.

Inclusion Criteria
- A diagnosis of wAMD.
- Patients for whom the decision to initiate treatment with IVT aflibercept in a proactive regimen was made as routine clinical practice.
- Treatment-naïve in the study eye (no prior therapy for wAMD).
- Patient age ≥50 years of age.
- Written informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).
Exclusion Criteria
- Participation in an investigational program with interventions outside of routine clinical practice.
- Patients with contraindications to IVT aflibercept listed in the local marketing authorization.
- Planned treatment regimen outside of the local marketing authorization.
- Patients with eye diseases, e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye.
- Concomitant ocular or systemic administration of drugs up to 3 months before IVT aflibercept treatment that could interfere with or potentiate the mechanism of action of IVT aflibercept, including other anti-VEGF agents in the fellow eye.
- Any other retinal disease which may interfere with the treatment of wAMD.

Trial Summary

Enrollment Goal
1563
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, Argentina

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Active, not recruiting
 
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Many Locations

Many Locations, Australia

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Active, not recruiting
 
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Many Locations

Many Locations, Belgium

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Active, not recruiting
 
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Many Locations

Many Locations, Canada

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Active, not recruiting
 
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Many Locations

Many Locations, China

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Active, not recruiting
 
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Many Locations

Many Locations, Denmark

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Active, not recruiting
 
Locations

Many Locations

Many Locations, France

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Active, not recruiting
 
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Many Locations

Many Locations, Ireland

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Active, not recruiting
 
Locations

Many Locations

Many Locations, Norway

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Active, not recruiting
 
Locations

Many Locations

Many Locations, South Korea

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Active, not recruiting
 
Locations

Many Locations

Many Locations, Spain

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Active, not recruiting
 
Locations

Many Locations

Many Locations, Sweden

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Active, not recruiting
 
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Many Locations

Many Locations, Thailand

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Active, not recruiting
 
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Many Locations

Many Locations, United Kingdom

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Active, not recruiting
 
Locations

Many Locations

Many Locations, Colombia

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Active, not recruiting
 
Locations

Many Locations

Many Locations, Italy

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Active, not recruiting
 
Locations

Many Locations

Many Locations, Switzerland

Status
Active, not recruiting
 

Trial Design