Macular EdemaNCT01445626
A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)
An observational study of Macular Edema, run by Allergan at 1 site in Germany.
Trial summary
This study will 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- dexamethasone intravitreal implant 0.7 mg
- Type of treatment
- Injection or infusion
- How many people
- 87 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Jan 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 who received at least 2 injections of OZURDEX® to treat macular oedema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in at least 1 eye.
Who may be able to join
- Macular oedema in the study eye due to BRVO or CRVO
- Received at least 2 OZURDEX® injections in the study eye
Who cannot join
- Received OZURDEX® injections as part of or during any clinical study
Trial locations and contacts
1 site in 1 country.
About this study
This study will 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).
- Conditions
- Macular Edema
- Being tested
- dexamethasone intravitreal implant 0.7 mg
- Medical subject headings
- 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®
Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections. 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
Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.
Measured: Up to 12 months
Secondary outcomes (6)
Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement.
Measured: Baseline, 7 to 12 weeks following the last injection
Percentage of Patients With an Increase of 2 Lines or More in BCVA
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.
Measured: Baseline, Up to 12 months
Percentage of Patients With an Increase of 3 Lines or More in BCVA
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.
Measured: Baseline, Up to 12 months
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement.
Measured: Baseline, 7 to 12 weeks following the last injection
Time to Improvement of 2 Lines or More in BCVA
Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).
Measured: Baseline, Up to 12 months
Time to Improvement of 3 Lines or More in BCVA
Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).
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 posted4 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionJan 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 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
- 87 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
- NCT01445626
- Sponsor's protocol ID
- MAF/AGN/OPH/RET/010
- Status last verified
- Jan 2013
- First submitted
- 30 Sep 2011
- Last updated
- 18 Feb 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 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)
- ClinicalTrials.gov ID
- NCT01445626
- Acronym / sponsor ID
- MAF/AGN/OPH/RET/010
- Conditions
- Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Oct 2011 (estimated)
- Results
- Posted 18 Feb 2013
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 efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular oedema due to Retinal Vein Occlusion (RVO).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Drug: dexamethasone intravitreal implant 0.7 mgPatients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received at least 2 injections of OZURDEX® to treat macular oedema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in at least 1 eye.
Key inclusion criteria (2 listed)
- Macular oedema in the study eye due to BRVO or CRVO
- Received at least 2 OZURDEX® injections in the study eye
Key exclusion criteria (1 listed)
- Received OZURDEX® injections as part of or during 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 intravitreal implant 0.7 mgAlso: OZURDEX®Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice. | Drug | All participants |
Primary outcome
Time to OZURDEX® Re-injection
Time frame: Up to 12 months
Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.
6 secondary outcomes
Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection
Time frame: Baseline, 7 to 12 weeks following the last injection
Percentage of Patients With an Increase of 2 Lines or More in BCVA
Time frame: Baseline, Up to 12 months
Percentage of Patients With an Increase of 3 Lines or More in BCVA
Time frame: Baseline, Up to 12 months
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection
Time frame: Baseline, 7 to 12 weeks following the last injection
Time to Improvement of 2 Lines or More in BCVA
Time frame: Baseline, Up to 12 months
Time to Improvement of 3 Lines or More in BCVA
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 18 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Diabetic Macular Edema (DME)
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Diabetic Macular Edema, Diabetic Retinopathy
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, run by Allergan at 1 site in Germany.
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 18 Feb 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 Germany. 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 18 Feb 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 (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 18 Feb 2013.