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

October 26, 2023 updated by: Bayer

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

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

1563

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Multiple Locations, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Approximately 2.000 patients from sites in Asia-Pacific, Europe, Latin America and North America.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
wAMD patients
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.
As prescribed by the treating physician according to the local label. No IVT aflibercept will be provided due to a nature of observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in BCVA (best corrected visual acuity)
Time Frame: 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.
Baseline to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2019

Primary Completion (Actual)

July 7, 2023

Study Completion (Actual)

October 17, 2023

Study Registration Dates

First Submitted

May 4, 2019

First Submitted That Met QC Criteria

May 4, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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