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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mCNV patients | Adult Canadian patients diagnosed with myopic choroidal neovascularization (mCNV) and naïve for anti-VEGF treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | As prescribed by the treating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Central retinal thickness (in μm) measured by Optical coherence tomography (OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients to be enrolled into the study must have been diagnosed with mCNV and started anti-VEGF treatment with aflibercept.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Canada |
Availability of this study's data will later 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.vivli.org 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 member section of the portal.
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Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT). |
| At baseline, 6 and 12 months |
| Number of treatment-emergent adverse events (TEAS's) | TEAEs comprise both ocular and non-ocular TEAEs | Baseline to 12 months |
| Severity of treatment-emergent adverse events | TEAEs comprise both ocular and non-ocular TEAEs | Baseline to 12 months |
| 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 | Imaging assessments as : OCT- Optical coherence tomography; OCTA- Optical coherence tomography angiography; FA- Fluorescein angiography and ICGA- Indocyanine green angiography | At 12 months |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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