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

Bayer

Status: Completed

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study type: Observational

Funder types: Industry

Identifiers

NCT04641234

21573

Details and patient eligibility

About

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.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

330 participants in 1 patient group

Cohort 1

Description:

Adult Belgian patients diagnosed with neovascular age-related macular degeneration (nAMD) with treatment-naïve study eye.

Treatment:

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)