- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03939767
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
Conditions
Intervention / Treatment
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
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Multiple Locations, Argentina
- Many Locations
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Multiple Locations, Australia
- Many Locations
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Multiple Locations, Belgium
- Many Locations
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Multiple Locations, Canada
- Many Locations
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Multiple Locations, China
- Many Locations
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Multiple Locations, Colombia
- Many Locations
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Multiple Locations, Denmark
- Many Locations
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Multiple Locations, France
- Many Locations
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Multiple Locations, Ireland
- Many Locations
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Multiple Locations, Italy
- Many Locations
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Multiple Locations, Korea, Republic of
- Many Locations
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Multiple Locations, Norway
- Many Locations
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Multiple Locations, Spain
- Many Locations
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Multiple Locations, Sweden
- Many Locations
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Multiple Locations, Switzerland
- Many Locations
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Multiple Locations, Thailand
- Many Locations
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Multiple Locations, United Kingdom
- Many Locations
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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 |
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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.
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As prescribed by the treating physician according to the local label.
No IVT aflibercept will be provided due to a nature of observational study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The change in BCVA (best corrected visual acuity)
Time Frame: Baseline to 12 months
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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.
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Baseline to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The change in BCVA
Time Frame: Baseline to 24 and 36 months
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Baseline to 24 and 36 months
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The change in BCVA by intended treatment regimen
Time Frame: Baseline to 12, 24 and 36 months
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Baseline to 12, 24 and 36 months
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The proportion of patients (eyes) gaining or losing a visual acuity compared to baseline
Time Frame: Baseline at 12, 24 and 36 months
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With letter score of ≥ 0 letters, ≥5 letters, ≥ 10 letters, ≥ 15 letters.
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Baseline at 12, 24 and 36 months
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The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better
Time Frame: At 12, 24 and 36 months
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At 12, 24 and 36 months
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The changes in central retinal thickness (CRT)
Time Frame: Baseline to 12, 24 and 36 months
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Baseline to 12, 24 and 36 months
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The number of injections
Time Frame: Baseline to 12, 24 and 36 months
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Baseline to 12, 24 and 36 months
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The distribution of the intervals between injections
Time Frame: Up to 36 months
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Up to 36 months
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20359
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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