Retinal Vein OcclusionNCT01568021
Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)
An observational study of Retinal Vein Occlusion and Macular Edema, run by Allergan at 3 sites in 3 countries.
Trial summary
This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in clinical practice, and will assess the time at which patients are considered for retreatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion, Macular Edema
- How many people
- 100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2011to Nov 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with BRVO and CRVO prescribed OZURDEX®
Who may be able to join
- Macular Edema
- Prescribed OZURDEX®
Who cannot join
- None
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in clinical practice, and will assess the time at which patients are considered for retreatment.
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Being tested
- No Intervention
- 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.
No InterventionOther
No intervention was administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| OZURDEX® | Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Re-treatment
Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye.
Measured: 1 Year
Secondary outcomes (2)
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score
BCVA was measured in the study eye using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision improved.
Measured: Baseline, Weeks 12, 24 and 48
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement.
Measured: Baseline, Weeks 12, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startOct 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568021
- Sponsor's protocol ID
- MAF/AGN/OPH/RET/007
- Status last verified
- Jan 2015
- First submitted
- 29 Mar 2012
- Last updated
- 10 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)
- ClinicalTrials.gov ID
- NCT01568021
- Acronym / sponsor ID
- MAF/AGN/OPH/RET/007
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Posted 10 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in clinical practice, and will assess the time at which patients are considered for retreatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OZURDEX® | – | Other: No InterventionSingle dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with BRVO and CRVO prescribed OZURDEX®
Key inclusion criteria (2 listed)
- Macular Edema
- Prescribed OZURDEX®
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No InterventionNo intervention was administered in this study. | Other | OZURDEX® |
Primary outcome
Time to First Re-treatment
Time frame: 1 Year
Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye.
2 secondary outcomes
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score
Time frame: Baseline, Weeks 12, 24 and 48
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Time frame: Baseline, Weeks 12, 24 and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Allergan
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Vein Occlusion and Macular Edema, run by Allergan at 3 sites in 3 countries.
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 2 inclusion and 1 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 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Norway, Sweden. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to First Re-treatment (time frame: 1 Year). 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 Feb 2015.