Retinal Vein OcclusionNCT01539577
A Long-Term Safety Study of OZURDEX® in Clinical Practice
An observational study of Retinal Vein Occlusion and Macular Edema, run by Allergan at 4 sites in 4 countries.
Trial summary
This study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion, Macular Edema, Uveitis, Posterior
- What is being tested?
- dexamethasone 700 μg intravitreal implant
- How many people
- 875 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Mar 2012to Mar 2016
- 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 with macular oedema due to CRVO or BRVO or non-infectious uveitis
Who may be able to join
- Macular oedema following either BRVO or CRVO or non-infectious uveitis
- Requires treatment with OZURDEX®
Who cannot join
- Current participation in any clinical study
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
This study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice.
- Conditions
- Retinal Vein Occlusion, Macular Edema, Uveitis, Posterior
- Being tested
- dexamethasone 700 μg intravitreal implant
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema, Uveitis, Posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone 700 μg intravitreal implantDrug
Also called OZURDEX®
dexamethasone 700 μg intravitreal implant administered according to general clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| OZURDEX® | OZURDEX® (dexamethasone 700 μg intravitreal implant) administered according to general clinical practice. Receives: Drug: dexamethasone 700 μg intravitreal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Patients Reporting Serious Adverse Events
Measured: 2 years
Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest
The ophthalmic adverse events of special interest include: increased intraocular pressure, glaucoma, ocular hypertension, cataract formation and progression, vitreous detachment, haemorrhage, endophthalmitis (infectious/ non-infectious), retinitis secondary to reactivation of latent viral or other ophthalmic infections, retinal tear/detachment, significant vitreous leak or hypotony, systemic corticosteroid effects, and mechanical failure of device and implant misplacement.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2016
- Study completionMar 2016
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.
- 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
- 875 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
- NCT01539577
- Sponsor's protocol ID
- 206207-025
- Status last verified
- Apr 2016
- First submitted
- 22 Feb 2012
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Safety Study of OZURDEX® in Clinical Practice
- ClinicalTrials.gov ID
- NCT01539577
- Acronym / sponsor ID
- 206207-025
- Conditions
- Retinal Vein Occlusion, Macular Edema, Uveitis, Posterior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 875 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Feb 2012 (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 study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OZURDEX® | – | Drug: dexamethasone 700 μg intravitreal implantOZURDEX® (dexamethasone 700 μg intravitreal implant) administered according to general clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with macular oedema due to CRVO or BRVO or non-infectious uveitis
Key inclusion criteria (2 listed)
- Macular oedema following either BRVO or CRVO or non-infectious uveitis
- Requires treatment with OZURDEX®
Key exclusion criteria (1 listed)
- Current participation in any clinical study
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 |
|---|---|---|
| dexamethasone 700 μg intravitreal implantAlso: OZURDEX®dexamethasone 700 μg intravitreal implant administered according to general clinical practice. | Drug | OZURDEX® |
Primary outcome
Incidence of Patients Reporting Serious Adverse Events
Time frame: 2 years
Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest
Time frame: 2 years
The ophthalmic adverse events of special interest include: increased intraocular pressure, glaucoma, ocular hypertension, cataract formation and progression, vitreous detachment, haemorrhage, endophthalmitis (infectious/ non-infectious), retinitis secondary to reactivation of latent viral or other ophthalmic infections, retinal tear/detachment, significant vitreous leak or hypotony, systemic corticosteroid effects, and mechanical failure of device and implant misplacement.
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 20 Apr 2016.
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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
4 sites in 4 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 4 sites in 4 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 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Spain, United Kingdom. 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?
Incidence of Patients Reporting Serious Adverse Events (time frame: 2 years). The study lists 2 primary outcomes in all. 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 20 Apr 2016.