Assessment of Proactive Treatments in Patients With Wet Age-related Macular Degeneration (wAMD) Which Have Never Undergone Treatment of This Particular Disease (XTEND)

Bayer

Status: Completed

Conditions: Wet Age-related Macular Degeneration

Treatments: Drug: Aflibercept (Eylea, BAY86-5321)

Study type: Observational

Funder types: Industry

Identifiers

NCT03939767

20359

Details and patient eligibility

About

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.

Enrollment: 1,563 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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 design

1,563 participants in 1 patient group

wAMD patients

Description:

Patients with a diagnosis of wAMD and naïve to any treatment in the study eye will be enrolled after the decision by treating physician for IVT aflibercept therapy according to the local label.

Treatment:

Drug: Aflibercept (Eylea, BAY86-5321)