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

Completed

• Conditions: Wet Age-related Macular Degeneration
• Interventions: Drug: Aflibercept (Eylea, BAY86-5321)

• Registration Number: NCT03939767
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-04
• Study First Submitted QC: 2019-05-04
• Study First Posted: 2019-05-07
• Study Start: 2019-05-12
• Primary Completion: 2023-07-07
• Status Verified: 2023-10
• Study Completion: 2023-10-17
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1563

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
wAMD patients	Aflibercept (Eylea, BAY86-5321)	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.

Primary Outcome Measures

Name	Time	Method
The change in BCVA (best corrected visual acuity)	Baseline to 12 months	In treatment-naïve wAMD patients treated with IVT aflibercept in a flexible proactive treatment pattern (fixed dosing or T\&E (Treat and Extend Regimen)) by label regimen.

Secondary Outcome Measures

Name	Time	Method
The change in BCVA	Baseline to 24 and 36 months
The change in BCVA by intended treatment regimen	Baseline to 12, 24 and 36 months
The proportion of patients (eyes) gaining or losing a visual acuity compared to baseline	Baseline at 12, 24 and 36 months	With letter score of ≥ 0 letters, ≥5 letters, ≥ 10 letters, ≥ 15 letters.
The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better (approximately 73 ETDRS letters)	At 12, 24 and 36 months
The changes in central retinal thickness (CRT)	Baseline to 12, 24 and 36 months
The number of injections	Baseline to 12, 24 and 36 months
The distribution of the intervals between injections	Up to 36 months

Trial Locations

Locations (1)

Many Locations; 🇬🇧 Multiple Locations, United Kingdom