A Study Reviewing Medical Records to Learn More About Treat-and-extend With Eylea in Patients With Neovascular Age-related Macular Degeneration (nAMD).
NCT ID: NCT04641234
Last Updated: 2022-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
330 participants
OBSERVATIONAL
2020-12-11
2021-06-09
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1
Adult Belgian patients diagnosed with neovascular age-related macular degeneration (nAMD) with treatment-naïve study eye.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
As prescribed by the treating physician
Interventions
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Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
As prescribed by the treating physician
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with eye diseases that required surgery during the first 24 months of aflibercept treatment, e.g. advanced glaucoma, visually significant cataracts.
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Many Locations
Multiple Locations, , Belgium
Countries
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Other Identifiers
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21573
Identifier Type: -
Identifier Source: org_study_id
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