Retinal Vein OcclusionNCT01411696
Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)
An observational study of Retinal Vein Occlusion and Macular Edema, run by Allergan at 1 site in United States.
Trial summary
This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion, Macular Edema
- What is being tested?
- dexamethasone intravitreal implant 0.7 mg
- Type of treatment
- Injection or infusion
- How many people
- 289 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Mar 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 edema due to RVO in at least one eye.
Who may be able to join
- Macular edema
- Received at least 2 OZURDEX® injections
Who cannot join
- Received OZURDEX® injections as part of a clinical study
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review.
- Conditions
- Retinal Vein Occlusion, Macular Edema
- 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®
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 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema. 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.
Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.
Measured: Baseline, 4 to 20 weeks after last injection (Up to 6 months)
Secondary outcomes (3)
Percentage of Participants 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 (worst) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.
Measured: Baseline, Up to 6 months
Percentage of Participants 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 (worst) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.
Measured: Baseline, Up to 6 months
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each 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 4 to 20 weeks after each injection. A negative change from baseline indicates improvement.
Measured: Baseline, 4 to 20 Weeks after Each injection (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2012
- Study completionMar 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 289 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
- NCT01411696
- Sponsor's protocol ID
- GMA-OZU-09-011
- Other IDs
- GMA-320
- Status last verified
- Mar 2013
- First submitted
- 5 Aug 2011
- Last updated
- 16 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dugel PU, Capone A Jr, Singer MA, Dreyer RF, Dodwell DG, Roth DB, Shi R, Walt JG, Scott LC, Hollander DA; SHASTA Study Group. Two or more dexamethasone intravitreal implants in treatment-naive patients with macular edema due to retinal vein occlusion: subgroup analysis of a retrospective chart review study. BMC Ophthalmol. 2015 Sep 4;15:118. doi: 10.1186/s12886-015-0106-z.
PubMed 26337664Singer MA, Capone A Jr, Dugel PU, Dreyer RF, Dodwell DG, Roth DB, Shi R, Walt JG, Scott LC, Hollander DA; SHASTA Study Group. Two or more dexamethasone intravitreal implants as monotherapy or in combination therapy for macular edema in retinal vein occlusion: subgroup analysis of a retrospective chart review study. BMC Ophthalmol. 2015 Apr 1;15:33. doi: 10.1186/s12886-015-0018-y.
PubMed 25885285
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)
- ClinicalTrials.gov ID
- NCT01411696
- Acronym / sponsor ID
- GMA-OZU-09-011
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Posted 16 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review.
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 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema. |
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 edema due to RVO in at least one eye.
Key inclusion criteria (2 listed)
- Macular edema
- Received at least 2 OZURDEX® injections
Key exclusion criteria (1 listed)
- Received OZURDEX® injections as part of a 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
Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection
Time frame: Baseline, 4 to 20 weeks after last injection (Up to 6 months)
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.
3 secondary outcomes
Percentage of Participants With an Increase of 2 Lines or More in BCVA
Time frame: Baseline, Up to 6 months
Percentage of Participants With an Increase of 3 Lines or More in BCVA
Time frame: Baseline, Up to 6 months
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection
Time frame: Baseline, 4 to 20 Weeks after Each injection (up to 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26337664Dugel PU, Capone A Jr, Singer MA, Dreyer RF, Dodwell DG, Roth DB, Shi R, Walt JG, Scott LC, Hollander DA; SHASTA Study Group. Two or more dexamethasone intravitreal implants in treatment-naive patients with macular edema due to retinal vein occlusion: subgroup analysis of a retrospective chart review study. BMC Ophthalmol. 2015 Sep 4;15:118. doi: 10.1186/s12886-015-0106-z.
- Derived from this study: PubMed 25885285Singer MA, Capone A Jr, Dugel PU, Dreyer RF, Dodwell DG, Roth DB, Shi R, Walt JG, Scott LC, Hollander DA; SHASTA Study Group. Two or more dexamethasone intravitreal implants as monotherapy or in combination therapy for macular edema in retinal vein occlusion: subgroup analysis of a retrospective chart review study. BMC Ophthalmol. 2015 Apr 1;15:33. doi: 10.1186/s12886-015-0018-y.
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Retinal Vein Occlusion (RVO)
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 Edema, run by Allergan at 1 site in United States.
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 16 Apr 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 United States. 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 16 Apr 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?
Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection (time frame: Baseline, 4 to 20 weeks after last injection (Up to 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01411696, which also lists 2 linked publications.
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 16 Apr 2013.