Retinal Vein OcclusionNCT01566526
Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion
An observational study of Retinal Vein Occlusion and Macular Oedema, run by Allergan at 1 site in Belgium.
Trial summary
The purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs Program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion, Macular Oedema
- What is being tested?
- dexamethasone intravitreal implant 0.7 mg
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2012to Jun 2012
- 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 branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of the Belgium Medical Needs Program.
Who may be able to join
- Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
- Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.
- Conditions
- Retinal Vein Occlusion, Macular Oedema
- Being tested
- dexamethasone intravitreal implant 0.7 mg
- 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.
dexamethasone intravitreal implant 0.7 mgDrug
Also called OZURDEX®
OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
| Study group | Role | What they receive |
|---|---|---|
| Patients Previously Treated with OZURDEX® | OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program. Receives: Drug: dexamethasone intravitreal implant 0.7 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to OZURDEX® Re-Injection in the Study Eye
The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.
Measured: Up to 12 Months
Secondary outcomes (6)
Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye
BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart and is 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 has improved. Data are reported for the 7-12 week period following the last injection.
Measured: Baseline, 7 to 12 weeks following the last injection
Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye
BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.
Measured: Baseline, Up to 12 Months
Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye
BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.
Measured: Baseline, Up to 12 Months
Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection
OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Data are reported for the 7-12 week period following the last injection.
Measured: Baseline, 7 to 12 weeks following the last injection
Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.
Measured: Baseline, Up to 12 Months
Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.
Measured: Baseline, Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJun 2012
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
- Retrospective
- Enrolment
- 26 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
- NCT01566526
- Sponsor's protocol ID
- MAF/AGN/OPH/RET/012
- Status last verified
- Mar 2013
- First submitted
- 27 Mar 2012
- Last updated
- 27 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT01566526
- Acronym / sponsor ID
- MAF/AGN/OPH/RET/012
- Conditions
- Retinal Vein Occlusion, Macular Oedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Posted 27 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Previously Treated with OZURDEX® | – | Drug: dexamethasone intravitreal implant 0.7 mgOZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of the Belgium Medical Needs Program.
Key inclusion criteria (2 listed)
- Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
- Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program
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 |
|---|---|---|
| dexamethasone intravitreal implant 0.7 mgAlso: OZURDEX®OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program. | Drug | Patients Previously Treated with OZURDEX® |
Primary outcome
Time to OZURDEX® Re-Injection in the Study Eye
Time frame: Up to 12 Months
The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.
6 secondary outcomes
Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye
Time frame: Baseline, 7 to 12 weeks following the last injection
Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye
Time frame: Baseline, Up to 12 Months
Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye
Time frame: Baseline, Up to 12 Months
Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection
Time frame: Baseline, 7 to 12 weeks following the last injection
Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline, Up to 12 Months
Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline, Up to 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- 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
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 and Macular Oedema, run by Allergan at 1 site in Belgium.
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 27 May 2013. 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 Belgium. 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 27 May 2013). 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 OZURDEX® Re-Injection in the Study Eye (time frame: Up to 12 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 27 May 2013.