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

Belgian Retrospective Chart Review Evaluating Treat-and-extend With Eylea® in Treatment naïve Patients With Neovascular Age-related Macular Degeneration.

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

• Study Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• Belgium
  • Multiple Locations, Belgium
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); As prescribed by the treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Definition of 'most stable injection interval according to the ophthalmologist	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	BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.	Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Central retinal thickness (in μm) measured by Optical coherence tomography (OCT)	Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT).	Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of patients with presence of fluid or anatomical parameters (IRF/SRF/PED)	IRF:Intra-Retinal Fluid/ SRF: Sub-Retinal Fluid / PED:Pigment Epithelial Detachment	Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of patients with absence of fluid or anatomical parameters (IRF/SRF/PED)		Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Reason for discontinuation of aflibercept treatment after 24 months	Reasons : Adverse event, lack of efficacy, remission and stop monitoring, remission and start monitor-and-extend, reimbursement issues, patients' decision, unknown	Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of patients discontinuing aflibercept treatment within the first 24 months		Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Reason for discontinuation of aflibercept treatment during first 24 months	Reasons :Adverse event, lack of efficacy, remission and stop monitoring, remission and start monitor-and-extend, reimbursement issues, patients' decision, unknown	Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of patients discontinuing aflibercept treatment after 24 months		Retrospective analysis from 01-Jan-2016 to 30-Nov-2020

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Actual): June 9, 2021
• Study Completion (Actual): June 9, 2021

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: aflibercept; Retinal disorders; treat-and-extend
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 21573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No