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

Neovascular Age-related Macular Degeneration Clinical Trial

— BELUGA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04641234
• Other study ID #: 21573
• Status: Completed
• Start date: December 11, 2020
• Est. completion date: June 9, 2021

Study information

• Verified date: June 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: June 9, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
As prescribed by the treating physician

Locations

Country	Name	City	State
Belgium	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Number of aflibercept injections during the 1st, 3rd and 4th year of treatment		Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Secondary	Last injection interval in the 1st, 3rd and 4th year		Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Secondary	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
Secondary	Number of monitoring visits during each year of the study		Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients with absence of fluid or anatomical parameters (IRF/SRF/PED)		Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Secondary	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
Secondary	Number of patients discontinuing aflibercept treatment within the first 24 months		Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Secondary	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
Secondary	Number of patients discontinuing aflibercept treatment after 24 months		Retrospective analysis from 01-Jan-2016 to 30-Nov-2020