A Study to Learn More About How Drug Aflibercept Works in Canadian Patients With Reduced Vision Caused by New Blood Vessels Growing in the Eye (Myopic Choroidal Neovascularization or mCNV)

Myopic Choroidal Neovascularization Clinical Trial

— REALM  

Official title:

A REtrospective Non-interventional Study to Assess the Effectiveness of AfLibercept in Patients With Myopic CNV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04524910
• Other study ID #: 20196
• Status: Completed
• Start date: June 16, 2021
• Est. completion date: November 11, 2022

Study information

• Verified date: June 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Being short sighted means that vision is blurry when looking at things far away. People with a condition called "pathologic myopia" are short sighted due to problems in the back layer of their eyes, also known as the retina. Some people with pathologic myopia can develop a serious condition called myopic choroidal neovascularization (mCNV). In people with mCNV, new blood vessels grow into the retina. These blood vessels can break, leaking blood or fluid into the retina. This can cause blurry vision or a loss of vision. In this study, researchers will find out more about how well drug aflibercept works and how safe it is in Canadian patients with mCNV. The researchers in this study will review information from the patients' eye doctor visits. The patients in this study will include Canadian men and women who started receiving aflibercept between May 2017 and August 2019. These patients were at least 18 years old and had not received treatment for their mCNV before. The researchers will look at the results of vision tests to find out how well the patients could read from a distance after they received aflibercept for 6 months. They will compare the results of these tests to before the patients received treatment. They will also learn more about how safe it is to have aflibercept injection into the eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 11, 2022
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (Age = 18 years) female or male patient.
• Anti-VEGF treatment naïve patients diagnosed with mCNV.
• Initiation of treatment with aflibercept was made as per investigator's routine treatment practice between 01 MAY 2017 and 31 AUG 2019.

Exclusion Criteria:

• Any participation in an investigational program with interventions outside of routine clinical practice.
• Patients who have previously been treated with anti-VEGF intravitreal injections, systemic anti-VEGF or pro-VEGF treatments, as well as other intravitreal steroids or steroid implants for the study eye.
• Patients with another retinal disease (e.g. wet age-related macular degeneration,-wAMD; diabetic macular edema-DME; retinal vein occlusion-RVO), patients with advanced cataracts or glaucoma, or patients with scarring, fibrosis, or atrophy involving the center of the fovea.

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Myopia
• Myopic Choroidal Neovascularization
• Neovascularization, Pathologic

Intervention

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

Locations

Country	Name	City	State
Canada	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in best corrected visual acuity (BCVA) from baseline to 6 months	BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.	Baseline to 6 months
Secondary	Change in BCVA from baseline to 12 months	BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.	Baseline to 12 months
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).	At baseline, 6 and 12 months
Secondary	Number of treatment-emergent adverse events (TEAS's)	TEAEs comprise both ocular and non-ocular TEAEs	Baseline to 12 months
Secondary	Severity of treatment-emergent adverse events	TEAEs comprise both ocular and non-ocular TEAEs	Baseline to 12 months
Secondary	Time from diagnosis to first treatment		At 12 months
Secondary	Number of aflibercept treatments		At 12 months
Secondary	Number of clinic visits		At 12 months
Secondary	Number of visual acuity tests performed		At 12 months
Secondary	Number of imaging assessments performed		At 12 months
Secondary	Type of imaging assessments performed	Imaging assessments as : OCT- Optical coherence tomography; OCTA- Optical coherence tomography angiography; FA- Fluorescein angiography and ICGA- Indocyanine green angiography	At 12 months

External Links

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