An observational study in Myopic Choroidal Neovascularization, sponsored by Bayer. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by Bayer · Observational
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.
214 studies on the registry are indexed under Choroidal Neovascularization; 12 are open to participants now.
This study's enrollment of 28 is below the median of 79 across 42 observational studies indexed under Choroidal Neovascularization.
Browse Choroidal Neovascularization studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients to be enrolled into the study must have been diagnosed with mCNV and started anti-VEGF treatment with aflibercept.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: Baseline to 6 months
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.
Time frame: Baseline to 12 months
Central retinal thickness (in μm) measured by Optical coherence tomography (OCT)
Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT).
Time frame: At baseline, 6 and 12 months
Number of treatment-emergent adverse events (TEAS's)
TEAEs comprise both ocular and non-ocular TEAEs
Time frame: Baseline to 12 months
Severity of treatment-emergent adverse events
TEAEs comprise both ocular and non-ocular TEAEs
Time frame: Baseline to 12 months
Time from diagnosis to first treatment
Time frame: At 12 months
Number of aflibercept treatments
Time frame: At 12 months
Number of clinic visits
Time frame: At 12 months
Number of visual acuity tests performed
Time frame: At 12 months
Number of imaging assessments performed
Time frame: 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
Time frame: At 12 months
Plan to share: No — 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.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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