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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03939767

Recruitment Status Active, not recruiting

First Posted May 7, 2019

Last update posted September 28, 2020

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:Wet Age-related Macular Degeneration
  • Intervention/Treatment: Drug: Aflibercept (Eylea, BAY86-5321)
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 1586 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 2019
  • Estimated Primary Completion Date: May 2023
  • Estimated Study Completion Date: August 2023
Groups and Cohorts
Groups/Cohorts 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) [ 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 Outcome Measures: 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 [ 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 ]
Eligibility Criteria
  • Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • 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.
Criteria

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
Contacts
Locations
Show 17 Study Locations
Sponsors and Collaborators

Bayer

More Information
  • Responsible Party: Bayer
  • ClinicalTrials.gov Identifier: NCT03939767 History of Changes
  • Other Study ID Numbers: 20359
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: September 28, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Plan Description: Availability of this study's data will 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.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Macular Degeneration