REALM: 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)

Sponsor

Bayer (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04524910

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myopic Choroidal Neovascularization	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 16, 2021

Anticipated Primary Completion Date :

Sep 16, 2022

Anticipated Study Completion Date :

Sep 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
mCNV patients Adult Canadian patients diagnosed with myopic choroidal neovascularization (mCNV) and naïve for anti-VEGF treatment	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) As prescribed by the treating physician

Arm

Intervention/Treatment

mCNV patients

Adult Canadian patients diagnosed with myopic choroidal neovascularization (mCNV) and naïve for anti-VEGF treatment

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

As prescribed by the treating physician

Outcome Measures

Primary Outcome Measures

Change in best corrected visual acuity (BCVA) from baseline to 6 months [Baseline to 6 months]
BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.

Secondary Outcome Measures

Change in BCVA from baseline to 12 months [Baseline to 12 months]
BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.
Central retinal thickness (in μm) measured by Optical coherence tomography (OCT) [At baseline, 6 and 12 months]
Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT).
Number of treatment-emergent adverse events (TEAS's) [Baseline to 12 months]
TEAEs comprise both ocular and non-ocular TEAEs
Severity of treatment-emergent adverse events [Baseline to 12 months]
TEAEs comprise both ocular and non-ocular TEAEs
Time from diagnosis to first treatment [At 12 months]
Number of aflibercept treatments [At 12 months]
Number of clinic visits [At 12 months]
Number of visual acuity tests performed [At 12 months]
Number of imaging assessments performed [At 12 months]
Type of imaging assessments performed [At 12 months]
Imaging assessments as : OCT- Optical coherence tomography; OCTA- Optical coherence tomography angiography; FA- Fluorescein angiography and ICGA- Indocyanine green angiography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.