Clinical trial NCT04524910: 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)
Official title: A REtrospective Non-interventional Study to Assess the Effectiveness of AfLibercept in Patients With Myopic CNV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopic Choroidal Neovascularization
Keywords: Intravitreal Aflibercept
Choroidal Neovascularization
Vascular Endothelial Growth Factor (VEGF)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-08-24
Enrollment: 28
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 mCNV and started anti-VEGF treatment with aflibercept.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in best corrected visual acuity (BCVA) from baseline to 6 months
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in BCVA from baseline to 12 months
timeFrame: Baseline to 12 months
measure: Central retinal thickness (in μm) measured by Optical coherence tomography (OCT)
timeFrame: At baseline, 6 and 12 months
measure: Number of treatment-emergent adverse events (TEAS's)
timeFrame: Baseline to 12 months
measure: Severity of treatment-emergent adverse events
timeFrame: Baseline to 12 months
measure: Time from diagnosis to first treatment
timeFrame: At 12 months
measure: Number of aflibercept treatments
timeFrame: At 12 months
measure: Number of clinic visits
timeFrame: At 12 months
measure: Number of visual acuity tests performed
timeFrame: At 12 months
measure: Number of imaging assessments performed
timeFrame: At 12 months
measure: Type of imaging assessments performed
timeFrame: At 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Canada
facility: Many Locations
Study officials:
References: