NCT03939767

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,563

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
17 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

May 12, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2023

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

4.2 years

First QC Date

May 4, 2019

Last Update Submit

September 18, 2024

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • 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

  • +2 more secondary outcomes

Study Arms (1)

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.

Drug: Aflibercept (Eylea, BAY86-5321)

Interventions

Aflibercept (Eylea, BAY86-5321)DRUG

As prescribed by the treating physician according to the local label. No IVT aflibercept will be provided due to a nature of observational study.

wAMD patients

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Many Locations

Multiple Locations, Argentina

Location

Many Locations

Multiple Locations, Australia

Location

Many Locations

Multiple Locations, Belgium

Location

Many Locations

Multiple Locations, Canada

Location

Many Locations

Multiple Locations, China

Location

Many Locations

Multiple Locations, Colombia

Location

Many Locations

Multiple Locations, Denmark

Location

Many Locations

Multiple Locations, France

Location

Many Locations

Multiple Locations, Ireland

Location

Many Locations

Multiple Locations, Italy

Location

Many Locations

Multiple Locations, Norway

Location

Many Locations

Multiple Locations, South Korea

Location

Many Locations

Multiple Locations, Spain

Location

Many Locations

Multiple Locations, Sweden

Location

Many Locations

Multiple Locations, Switzerland

Location

Many Locations

Multiple Locations, Thailand

Location

Many Locations

Multiple Locations, United Kingdom

Location

Related Publications (2)

  • Bailey C, Chandran M, Gale R, Narendran N, Talks J, McGoey H, Keshk Z, Morgan-Warren P, Allmeier H, Machewitz T, Patel PJ, Varma D. 2-year results from an observational study of proactive treatment regimens with intravitreal aflibercept 2 mg in patients with nAMD in clinical practice: XTEND study UK cohort. Eye (Lond). 2025 Apr;39(6):1138-1145. doi: 10.1038/s41433-024-03550-y. Epub 2024 Dec 24.

    PMID: 39719502DERIVED

  • Korobelnik JF, Chaudhary V, Mitchell P, Kang SW, Tadayoni R, Allmeier H, Lee J, Zhang X, Machewitz T, Bailey C. XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration. Ophthalmol Ther. 2024 Mar;13(3):725-738. doi: 10.1007/s40123-023-00867-x. Epub 2024 Jan 10.

    PMID: 38198053DERIVED

Related Links

MeSH Terms

Interventions

aflibercept

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2019

First Posted

May 7, 2019

Study Start

May 12, 2019

Primary Completion

July 7, 2023

Study Completion

October 17, 2023

Last Updated

September 20, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

AU(1)DK(1)CH(1)ES(1)TH(1)GB(1)CA(1)CO(1)KR(1)FR(1)IT(1)NO(1)BE(1)IE(1)AR(1)SE(1)CN(1)