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

NCT04641234 | Completed

• 1 other identifier: 21573
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Retinal disorders; aflibercept; treat-and-extend

Outcome Measures

Primary Outcomes (2)

• Number of injections in the first 24 months of treatment

  Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)

• Last injection interval in the 2nd year of treatment

  Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)

Secondary Outcomes (12)

• Number of aflibercept injections during the 1st, 3rd and 4th year of treatment

  Retrospective analysis from 01-Jan-2016 to 30-Nov-2020

• Last injection interval in the 1st, 3rd and 4th year

  Retrospective analysis from 01-Jan-2016 to 30-Nov-2020

• Most stable interval between aflibercept injections in the 2nd, 3rd and 4th year

  Retrospective analysis from 01-Jan-2016 to 30-Nov-2020

• Number of monitoring visits during each year of the study

  Retrospective analysis from 01-Jan-2016 to 30-Nov-2020

• Change in best corrected visual acuity (BCVA) from baseline to 90 days and after each year in the study

  Retrospective analysis from 01-Jan-2016 to 30-Nov-2020

Study Arms (1)

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)

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) DRUG

As prescribed by the treating physician

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Belgium

Location

MeSH Terms

Conditions

Retinal Diseases

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 23, 2020
• Study Start: December 11, 2020
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

BE (1)