Macular EdemaNCT02181530
Retrospective Data Collection Study in Patients With Macular Oedema Receiving OZURDEX®
An observational study of Macular Edema and Retinal Vein Occlusion, run by Allergan at 1 site in Poland.
Trial summary
This study will use retrospective data to evaluate the safety and efficacy of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as part of this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Edema, Retinal Vein Occlusion
- How many people
- 43 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2014to Oct 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of routine clinical practice.
Who may be able to join
- Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO)
- Received at least one injection of OZURDEX® in the study eye
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This study will use retrospective data to evaluate the safety and efficacy of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as part of this study.
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Being tested
- No Intervention
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No treatment (intervention) is being administered as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| OZURDEX® | Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved.
Measured: Baseline, 7 to 12 weeks following the first OZURDEX® injection
Secondary outcomes (6)
Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye
BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 2 lines or more indicates an improvement.
Measured: Baseline, Up to 17 Months
Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye
BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 3 lines or more indicates an improvement.
Measured: Baseline, Up to 17 Months
Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
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
Measured: Baseline, 7 to 12 weeks following the first OZURDEX® injection
Time to Improvement of 2 Lines or More in BCVA in the Study Eye
BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 2 or more lines is reported.
Measured: Baseline, Up to 17 Months
Time to Improvement of 3 Lines or More in BCVA in the Study Eye
BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 3 or more lines is reported.
Measured: Baseline, Up to 17 Months
Time to OZURDEX® Re-Injection in the Study Eye
Measured: Up to 17 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionOct 2014
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 Macular EdemaStudies 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
- 43 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
- NCT02181530
- Sponsor's protocol ID
- MAF/AGN/OPH/RET/016
- Status last verified
- May 2015
- First submitted
- 2 Jul 2014
- Last updated
- 25 May 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 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Collection Study in Patients With Macular Oedema Receiving OZURDEX®
- ClinicalTrials.gov ID
- NCT02181530
- Acronym / sponsor ID
- MAF/AGN/OPH/RET/016
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Jul 2014 (estimated)
- Results
- Posted 25 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use retrospective data to evaluate the safety and efficacy of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OZURDEX® | – | Other: No InterventionRetrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of routine clinical practice.
Key inclusion criteria (2 listed)
- Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO)
- Received at least one injection of OZURDEX® in the study eye
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 treatment (intervention) is being administered as part of this study. | Other | OZURDEX® |
Primary outcome
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline, 7 to 12 weeks following the first OZURDEX® injection
BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved.
6 secondary outcomes
Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye
Time frame: Baseline, Up to 17 Months
Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye
Time frame: Baseline, Up to 17 Months
Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Time frame: Baseline, 7 to 12 weeks following the first OZURDEX® injection
Time to Improvement of 2 Lines or More in BCVA in the Study Eye
Time frame: Baseline, Up to 17 Months
Time to Improvement of 3 Lines or More in BCVA in the Study Eye
Time frame: Baseline, Up to 17 Months
Time to OZURDEX® Re-Injection in the Study Eye
Time frame: Up to 17 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 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
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 Macular Edema and Retinal Vein Occlusion, run by Allergan at 1 site in Poland.
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 25 May 2015. 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 Poland. 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 25 May 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?
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye (time frame: Baseline, 7 to 12 weeks following the first OZURDEX® injection). 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 25 May 2015.