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Completed

NCT Number: NCT03939767

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

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.

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Key information

Conditions

Wet Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Multiple Locations, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The change in BCVA

    Time frame: Baseline to 24 and 36 months

  2. The change in BCVA by intended treatment regimen

    Time frame: Baseline to 12, 24 and 36 months

  3. 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.

  4. The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better (approximately 73 ETDRS letters)

    Time frame: At 12, 24 and 36 months

  5. The changes in central retinal thickness (CRT)

    Time frame: Baseline to 12, 24 and 36 months

  6. The number of injections

    Time frame: Baseline to 12, 24 and 36 months

  7. The distribution of the intervals between injections

    Time frame: Up to 36 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: XTEND

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 7, 2019
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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