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

Wet Age-related Macular Degeneration Clinical Trial

— XTEND  

Official title:

Evaluation of an eXtended and proacTive Dosing regimEn in Treatment-Naïve Patients With Wet Age-related Macular Degeneration (wAMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939767
• Other study ID #: 20359
• Status: Completed
• Start date: May 12, 2019
• Est. completion date: October 17, 2023

Study information

• Verified date: October 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1563
• Est. completion date: October 17, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Age-related Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, BAY86-5321)
As prescribed by the treating physician according to the local label. No IVT aflibercept will be provided due to a nature of observational study.

Locations

Country	Name	City	State
Argentina	Many Locations	Multiple Locations
Australia	Many Locations	Multiple Locations
Belgium	Many Locations	Multiple Locations
Canada	Many Locations	Multiple Locations
China	Many Locations	Multiple Locations
Colombia	Many Locations	Multiple Locations
Denmark	Many Locations	Multiple Locations
France	Many Locations	Multiple Locations
Ireland	Many Locations	Multiple Locations
Italy	Many Locations	Multiple Locations
Korea, Republic of	Many Locations	Multiple Locations
Norway	Many Locations	Multiple Locations
Spain	Many Locations	Multiple Locations
Sweden	Many Locations	Multiple Locations
Switzerland	Many Locations	Multiple Locations
Thailand	Many Locations	Multiple Locations
United Kingdom	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Canada,  China,  Colombia,  Denmark,  France,  Ireland,  Italy,  Korea, Republic of,  Norway,  Spain,  Sweden,  Switzerland,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in BCVA (best corrected visual acuity)	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.	Baseline to 12 months
Secondary	The change in BCVA		Baseline to 24 and 36 months
Secondary	The change in BCVA by intended treatment regimen		Baseline to 12, 24 and 36 months
Secondary	The proportion of patients (eyes) gaining or losing a visual acuity compared to baseline	With letter score of = 0 letters, =5 letters, = 10 letters, = 15 letters.	Baseline at 12, 24 and 36 months
Secondary	The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better		At 12, 24 and 36 months
Secondary	The changes in central retinal thickness (CRT)		Baseline to 12, 24 and 36 months
Secondary	The number of injections		Baseline to 12, 24 and 36 months
Secondary	The distribution of the intervals between injections		Up to 36 months