A Study Reviewing Medical Records to Learn More About Treat-and-extend With Eylea in Patients With Neovascular Age-related Macular Degeneration (nAMD).

Sponsor
Bayer
Study ID
NCT04641234
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 11, 2020
Status verified
Jun 2022
Primary completion
Jun 9, 2021
Completion
Jun 9, 2021

Study Design

Enrollment
330 participants (actual)

Arms

  • Arm: Cohort 1
    Adult Belgian patients diagnosed with neovascular age-related macular degeneration (nAMD) with treatment-naïve study eye.

Primary Outcome Measure

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) ]

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