Clinical trial NCT04641234: A Study Reviewing Medical Records to Learn More About Treat-and-extend With Eylea in Patients With Neovascular Age-related Macular Degeneration (nAMD).
Official title: Belgian Retrospective Chart Review Evaluating Treat-and-extend With Eylea® in Treatment naïve Patients With Neovascular Age-related Macular Degeneration.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age-related Macular Degeneration
Keywords: Retinal disorders
aflibercept
treat-and-extend
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Number of injections in the first 24 months of treatment
timeFrame: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)
measure: Last injection interval in the 2nd year of treatment
timeFrame: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)
Secondary outcomes:
measure: Number of aflibercept injections during the 1st, 3rd and 4th year of treatment
timeFrame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
measure: Last injection interval in the 1st, 3rd and 4th year
timeFrame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
measure: Most stable interval between aflibercept injections in the 2nd, 3rd and 4th year
timeFrame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
measure: Number of monitoring visits during each year of the study
timeFrame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
measure: Change in best corrected visual acuity (BCVA) from baseline to 90 days and after each year in the study
timeFrame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
measure: Central retinal thickness (in μm) measured by Optical coherence tomography (OCT)
timeFrame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
measure: Number of patients with presence of fluid or anatomical parameters (IRF/SRF/PED)
timeFrame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
measure: Number of patients with absence of fluid or anatomical parameters (IRF/SRF/PED)
timeFrame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
measure: Reason for discontinuation of aflibercept treatment after 24 months
timeFrame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
measure: Number of patients discontinuing aflibercept treatment within the first 24 months
timeFrame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
measure: Reason for discontinuation of aflibercept treatment during first 24 months
timeFrame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
measure: Number of patients discontinuing aflibercept treatment after 24 months
timeFrame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Other outcomes:
Locations:
city: Multiple Locations
country: Belgium
facility: Many Locations
Study officials:
References: