Retinal Vein OcclusionJPMS-CRVONCT02040220
Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Eylea for Central Retinal Vein Occlusion (CRVO)
An observational study of Retinal Vein Occlusion, run by Bayer at 1 site in Japan.
Trial summary
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of CRVO. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Type of treatment
- Injection or infusion
- How many people
- 385 participants
- Where
- 1 siteJapan
- Study dates
- 24 Jan 2014to 9 Nov 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female and male patients with a diagnosis of CRVO will be enrolled after the decision for treatment with EYLEA has been made by the investigator. Those patients prescribed EYLEA previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and familiarize themselves with the safety information in the product package label. Eligible patients who receive EYLEA will be enrolled and documented in the eCRF.
Who may be able to join
- Patients who start EYLEA treatment for CRVO
Who cannot join
- Patients who have already received EYLEA treatment
- Patients who are contraindicated based on approved label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Special Drug Use Investigation of EYLEA for CRVO
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of CRVO. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.
The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years.
Read more
For each patient, data are collected as defined in the case report form at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).
There will interim analysis of study data: 6 months after last patient first visit and J-PSUR(Japanese-Periodic Safety Update Report )
- Conditions
- Retinal Vein Occlusion
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Keywords
- CRVO, Macular edema, Aflibercept, anti-VEGF
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
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
2 mg of Eylea will be treated per one injection at more than one months interval usually.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Eylea treatment goup 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.
Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular)
Measured: 6 months after start of treatment with the drug
Secondary outcomes (2)
Effectiveness (visual acuity)
Measured: 6months after start of treatment with the drug
Effectiveness (retina thickness)
Measured: 6months after start of treatment with the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study start24 Jan 2014
- Primary completion1 Jun 2018
- Study completion9 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies 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
- Prospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040220
- Sponsor's protocol ID
- 16641
- Other IDs
- EYL-CRVO
- Acronym
- JPMS-CRVO
- Status last verified
- Apr 2019
- First submitted
- 8 Jan 2014
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation of EYLEA for CRVO
- ClinicalTrials.gov ID
- NCT02040220
- Acronym / sponsor ID
- JPMS-CRVO / 16641
- Conditions
- Retinal Vein Occlusion
- Keywords
- CRVO, Macular edema, Aflibercept, anti-VEGF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 24 Jan 2014 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 20 Jan 2014 (estimated)
- 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.
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of CRVO. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.
The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years.
For each patient, data are collected as defined in the case report form at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).
There will interim analysis of study data: 6 months after last patient first visit and J-PSUR(Japanese-Periodic Safety Update Report )
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Eylea treatment goup |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female and male patients with a diagnosis of CRVO will be enrolled after the decision for treatment with EYLEA has been made by the investigator. Those patients prescribed EYLEA previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and familiarize themselves with the safety information in the product package label. Eligible patients who receive EYLEA will be enrolled and documented in the eCRF.
Key inclusion criteria (1 listed)
- Patients who start EYLEA treatment for CRVO
Key exclusion criteria (2 listed)
- Patients who have already received EYLEA treatment
- Patients who are contraindicated based on approved label
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)2 mg of Eylea will be treated per one injection at more than one months interval usually. | Drug | Group 1 |
Primary outcome
Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular)
Time frame: 6 months after start of treatment with the drug
2 secondary outcomes
Effectiveness (visual acuity)
Time frame: 6months after start of treatment with the drug
Effectiveness (retina thickness)
Time frame: 6months after start of treatment with the drug
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 10 Apr 2019.
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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.
Bayer Study Director study director
Bayer
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 Retinal Vein Occlusion, run by Bayer at 1 site in Japan.
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 1 inclusion and 2 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 10 Apr 2019. 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 Japan. 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?
Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular) (time frame: 6 months after start of treatment with the drug). 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 10 Apr 2019.