Myopic Choroidal NeovascularizationREALMNCT04524910
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)
An observational study of Myopic Choroidal Neovascularization, run by Bayer at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopic Choroidal Neovascularization
- What is being tested?
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jun 2021to 11 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients to be enrolled into the study must have been diagnosed with mCNV and started anti-VEGF treatment with aflibercept.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A REtrospective Non-interventional Study to Assess the Effectiveness of AfLibercept in Patients With Myopic CNV
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.
Read more
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.
- Conditions
- Myopic Choroidal Neovascularization
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Keywords
- Intravitreal Aflibercept, Choroidal Neovascularization, Vascular Endothelial Growth Factor (VEGF)
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Drug
As prescribed by the treating physician
| Study group | Role | What they receive |
|---|---|---|
| mCNV patients | Adult Canadian patients diagnosed with myopic choroidal neovascularization (mCNV) and naïve for anti-VEGF treatment Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (10)
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.
Measured: 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).
Measured: At baseline, 6 and 12 months
Number of treatment-emergent adverse events (TEAS's)
TEAEs comprise both ocular and non-ocular TEAEs
Measured: Baseline to 12 months
Severity of treatment-emergent adverse events
TEAEs comprise both ocular and non-ocular TEAEs
Measured: Baseline to 12 months
Time from diagnosis to first treatment
Measured: At 12 months
Number of aflibercept treatments
Measured: At 12 months
Number of clinic visits
Measured: At 12 months
Number of visual acuity tests performed
Measured: At 12 months
Number of imaging assessments performed
Measured: 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
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start16 Jun 2021
- Primary completion17 Oct 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopic Choroidal NeovascularizationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524910
- Sponsor's protocol ID
- 20196
- Acronym
- REALM
- Status last verified
- Jun 2023
- First submitted
- 21 Aug 2020
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A REtrospective Non-interventional Study to Assess the Effectiveness of AfLibercept in Patients With Myopic CNV
- ClinicalTrials.gov ID
- NCT04524910
- Acronym / sponsor ID
- REALM / 20196
- Conditions
- Myopic Choroidal Neovascularization
- Keywords
- Intravitreal Aflibercept, Choroidal Neovascularization, Vascular Endothelial Growth Factor (VEGF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mCNV patients | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Adult Canadian patients diagnosed with myopic choroidal neovascularization (mCNV) and naïve for anti-VEGF treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients to be enrolled into the study must have been diagnosed with mCNV and started anti-VEGF treatment with aflibercept.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)As prescribed by the treating physician | Drug | mCNV patients |
Primary outcome
Change in best corrected visual acuity (BCVA) from baseline to 6 months
Time frame: Baseline to 6 months
BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.
10 secondary outcomes
Change in BCVA from baseline to 12 months
Time frame: Baseline to 12 months
Central retinal thickness (in μm) measured by Optical coherence tomography (OCT)
Time frame: At baseline, 6 and 12 months
Number of treatment-emergent adverse events (TEAS's)
Time frame: Baseline to 12 months
Severity of treatment-emergent adverse events
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
Time frame: At 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: 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.
Related trials for Myopic Choroidal Neovascularization
Not yet recruitingObservational study
Deep Learning-Based OCTA Quantification and Modeling for Predicting Long-Term Anti-VEGF Efficacy in mCNV
Myopic Choroidal Neovascularization
Not yet recruitingObservational study
The Treatment Burden of Myopic Choroidal Neovascularization
Myopic Choroidal Neovascularisation, Anti-VEGF Treatment
Not yet recruitingObservational study
An Interpretable Fundus Diseases Report Generating System Based On Weakly Labelings
Retinal Diseases, Choroidal Disease
Active, not recruiting
Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization
Nearsightedness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopic Choroidal Neovascularization, run by Bayer at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in best corrected visual acuity (BCVA) from baseline to 6 months (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.