Clincosm LogoSign in Get a demo

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

Sponsor
Bayer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03939767
Collaborator
(none)
1,563
Enrollment
17
Locations
51.1
Anticipated Duration (Months)
91.9
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aflibercept (Eylea, BAY86-5321)

Study Design

Study Type:
Observational
Actual Enrollment :
1563 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of an eXtended and proacTive Dosing regimEn in Treatment-Naïve Patients With Wet Age-related Macular Degeneration (wAMD)
Actual Study Start Date :
May 12, 2019
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Aug 15, 2023

Arms and Interventions

Arm 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.

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.

Outcome Measures

Primary Outcome Measures

  1. The change in BCVA (best corrected visual acuity) [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.

Secondary Outcome Measures

  1. The change in BCVA [Baseline to 24 and 36 months]

  2. The change in BCVA by intended treatment regimen [Baseline to 12, 24 and 36 months]

  3. The proportion of patients (eyes) gaining or losing a visual acuity compared to baseline [Baseline at 12, 24 and 36 months]

    With letter score of ≥ 0 letters, ≥5 letters, ≥ 10 letters, ≥ 15 letters.

  4. The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better [At 12, 24 and 36 months]

  5. The changes in central retinal thickness (CRT) [Baseline to 12, 24 and 36 months]

  6. The number of injections [Baseline to 12, 24 and 36 months]

  7. The distribution of the intervals between injections [Up to 36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Many Locations Multiple Locations Argentina
2 Many Locations Multiple Locations Australia
3 Many Locations Multiple Locations Belgium
4 Many Locations Multiple Locations Canada
5 Many Locations Multiple Locations China
6 Many Locations Multiple Locations Colombia
7 Many Locations Multiple Locations Denmark
8 Many Locations Multiple Locations France
9 Many Locations Multiple Locations Ireland
10 Many Locations Multiple Locations Italy
11 Many Locations Multiple Locations Korea, Republic of
12 Many Locations Multiple Locations Norway
13 Many Locations Multiple Locations Spain
14 Many Locations Multiple Locations Sweden
15 Many Locations Multiple Locations Switzerland
16 Many Locations Multiple Locations Thailand
17 Many Locations Multiple Locations United Kingdom

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT03939767
Other Study ID Numbers:
  • 20359
First Posted:
May 7, 2019
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Macular Degeneration
Aflibercept

Study Results

No Results Posted as of Aug 19, 2022