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Trial record 1 of 1 for:    NCT04641234
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A Study Reviewing Medical Records to Learn More About Treat-and-extend With Eylea in Patients With Neovascular Age-related Macular Degeneration (nAMD). (BELUGA)

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ClinicalTrials.gov Identifier: NCT04641234
Recruitment Status : Completed
First Posted : November 23, 2020
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:

In people with neovascular age-related macular degeneration (nAMD), the body makes too much of a protein called vascular endothelial growth factor (VEGF). This causes too many blood vessels to grow in a part of the eye called the macula. These blood vessels can damage the macula, causing dark spots and blurriness in central vision.

The study drug, aflibercept, works by reducing VEGF levels in the eye.It has already been approved for patients to receive as a treatment for nAMD in a fixed 8-weekly or treat-and-extend dosing regimen after having received 3 monthly doses at the start of treatment. In this study, the researchers want to learn more about how often patients received aflibercept and how their vision changed.

The study will include patients with nAMD who had not received treatment to reduce VEGF levels in the eye before. These patients will have started treatment with aflibercept between January 2016 and November 2018. The study will include about 330 men and women who are at least 18 years old.

All of the patients had received aflibercept eye injections based on their doctor's instructions. The researchers will use the patients' medical records from January 2016 to November 2020 to measure the following:

  • the number of aflibercept eye injections the patients received
  • how long the patients could wait between treatments
  • the change in the patients' vision
  • how many patients stopped treatment and why.
  • associations between patient and disease characteristics at the start of treatment with the number of aflibercept injections and patient's vision during treatment.

Condition or disease Intervention/treatment
Neovascular Age-related Macular Degeneration Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study Design
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Study Type : Observational
Actual Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Belgian Retrospective Chart Review Evaluating Treat-and-extend With Eylea® in Treatment naïve Patients With Neovascular Age-related Macular Degeneration.
Actual Study Start Date : December 11, 2020
Actual Primary Completion Date : June 9, 2021
Actual Study Completion Date : June 9, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cohort 1
Adult Belgian patients diagnosed with neovascular age-related macular degeneration (nAMD) with treatment-naïve study eye.
 Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
As prescribed by the treating physician


Outcome Measures
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Primary Outcome Measures :
  1. Number of injections in the first 24 months of treatment [ Time Frame: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020) ]
  2. Last injection interval in the 2nd year of treatment [ Time Frame: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020) ]

Secondary Outcome Measures :
  1. Number of aflibercept injections during the 1st, 3rd and 4th year of treatment [ Time Frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 ]
  2. Last injection interval in the 1st, 3rd and 4th year [ Time Frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 ]
  3. Most stable interval between aflibercept injections in the 2nd, 3rd and 4th year [ Time Frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 ]
    Definition of 'most stable injection interval according to the ophthalmologist

  4. Number of monitoring visits during each year of the study [ Time Frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 ]
  5. Change in best corrected visual acuity (BCVA) from baseline to 90 days and after each year in the study [ Time Frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 ]
    BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.

  6. Central retinal thickness (in μm) measured by Optical coherence tomography (OCT) [ Time Frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 ]
    Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT).

  7. Number of patients with presence of fluid or anatomical parameters (IRF/SRF/PED) [ Time Frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 ]
    IRF:Intra-Retinal Fluid/ SRF: Sub-Retinal Fluid / PED:Pigment Epithelial Detachment

  8. Number of patients with absence of fluid or anatomical parameters (IRF/SRF/PED) [ Time Frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 ]
  9. Reason for discontinuation of aflibercept treatment after 24 months [ Time Frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 ]
    Reasons : Adverse event, lack of efficacy, remission and stop monitoring, remission and start monitor-and-extend, reimbursement issues, patients' decision, unknown

  10. Number of patients discontinuing aflibercept treatment within the first 24 months [ Time Frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 ]
  11. Reason for discontinuation of aflibercept treatment during first 24 months [ Time Frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 ]
    Reasons :Adverse event, lack of efficacy, remission and stop monitoring, remission and start monitor-and-extend, reimbursement issues, patients' decision, unknown

  12. Number of patients discontinuing aflibercept treatment after 24 months [ Time Frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients to be enrolled into the study must have been diagnosed with neovascular age-related macular degeneration (nAMD) and started anti-VEGF treatment with aflibercept.
Criteria

Inclusion Criteria:

  • Adult (≥18 years) patients diagnosed with nAMD
  • Anti-VEGF treatment-naïve
  • Started Intravitreal (IVT) aflibercept treatment between 01 January 2016 and 30 November 2018
  • Aflibercept treatment according to Treat-and-Extend (T&E) immediately after the loading dose
  • Availability of medical records of aflibercept treatment.

Exclusion Criteria:

  • Participation in an investigational program with interventions outside of routine clinical practice during the aflibercept treatment
  • Patients with eye diseases that required surgery during the first 24 months of aflibercept treatment, e.g. advanced glaucoma, visually significant cataracts.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641234


Locations
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Belgium
Many Locations
Multiple Locations, Belgium
Sponsors and Collaborators
Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04641234    
Other Study ID Numbers: 21573
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Retinal disorders
aflibercept
treat-and-extend
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents