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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03939767




Registration number
NCT03939767
Ethics application status
Date submitted
4/05/2019
Date registered
7/05/2019

Titles & IDs
Public title
Assessment of Proactive Treatments in Patients With Wet Age-related Macular Degeneration (wAMD) Which Have Never Undergone Treatment of This Particular Disease
Scientific title
Evaluation of an eXtended and proacTive Dosing regimEn in Treatment-Naïve Patients With Wet Age-related Macular Degeneration (wAMD)
Secondary ID [1] 0 0
20359
Universal Trial Number (UTN)
Trial acronym
XTEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wet Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Aflibercept (Eylea, BAY86-5321)

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.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The change in BCVA (best corrected visual acuity)
Timepoint [1] 0 0
Baseline to 12 months
Secondary outcome [1] 0 0
The change in BCVA
Timepoint [1] 0 0
Baseline to 24 and 36 months
Secondary outcome [2] 0 0
The change in BCVA by intended treatment regimen
Timepoint [2] 0 0
Baseline to 12, 24 and 36 months
Secondary outcome [3] 0 0
The proportion of patients (eyes) gaining or losing a visual acuity compared to baseline
Timepoint [3] 0 0
Baseline at 12, 24 and 36 months
Secondary outcome [4] 0 0
The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better
Timepoint [4] 0 0
At 12, 24 and 36 months
Secondary outcome [5] 0 0
The changes in central retinal thickness (CRT)
Timepoint [5] 0 0
Baseline to 12, 24 and 36 months
Secondary outcome [6] 0 0
The number of injections
Timepoint [6] 0 0
Baseline to 12, 24 and 36 months
Secondary outcome [7] 0 0
The distribution of the intervals between injections
Timepoint [7] 0 0
Up to 36 months

Eligibility
Key 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).
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/10/2023
Sample size
Target
Accrual to date
Final
1563
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Many Locations - Multiple Locations
Recruitment postcode(s) [1] 0 0
- Multiple Locations
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Multiple Locations
Country [2] 0 0
Belgium
State/province [2] 0 0
Multiple Locations
Country [3] 0 0
Canada
State/province [3] 0 0
Multiple Locations
Country [4] 0 0
China
State/province [4] 0 0
Multiple Locations
Country [5] 0 0
Colombia
State/province [5] 0 0
Multiple Locations
Country [6] 0 0
Denmark
State/province [6] 0 0
Multiple Locations
Country [7] 0 0
France
State/province [7] 0 0
Multiple Locations
Country [8] 0 0
Ireland
State/province [8] 0 0
Multiple Locations
Country [9] 0 0
Italy
State/province [9] 0 0
Multiple Locations
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Multiple Locations
Country [11] 0 0
Norway
State/province [11] 0 0
Multiple Locations
Country [12] 0 0
Spain
State/province [12] 0 0
Multiple Locations
Country [13] 0 0
Sweden
State/province [13] 0 0
Multiple Locations
Country [14] 0 0
Switzerland
State/province [14] 0 0
Multiple Locations
Country [15] 0 0
Thailand
State/province [15] 0 0
Multiple Locations
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Multiple Locations

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03939767