Macular EdemaNCT01805323

A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema

An observational study of Macular Edema, run by Allergan at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This retrospective chart review study will describe the history of patients with retinal disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously administered according to general clinical practice. Read more about this study

Who is it for?: Any age
Conditions the study is for: Macular Edema
What is being tested?: Dexamethasone Intravitreal Implant
How many people: 101 participants
Where: 1 siteCanada
Study dates: 1 Sep 2012to 15 Apr 2013
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 macular edema

Who may be able to join

Retinal disease involving macular edema
Received at least one OZURDEX® injection

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Canada1 site

Study site
Québec, Quebec

Other trials in Canada

About this study

Conditions: Macular Edema
Being tested: Dexamethasone Intravitreal Implant
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 ImplantDrug
Also called OZURDEX®
Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice.

Study groups in NCT01805323
Study group	Role	What they receive
All Participants		Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice. Receives: Drug: Dexamethasone Intravitreal Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Mean Change From Baseline in Best Corrected Visual Acuity (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). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement.
Measured: Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)

Secondary outcomes (1)

Peak Mean Change From Baseline in Central Retinal Thickness (CRT)
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. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement.
Measured: Baseline, 2 to 26 weeks following last injection (up to 6.5 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201215 Apr 2013

First posted6 Mar 2013 (estimated)
Study start1 Sep 2012
Primary completion15 Apr 2013
Study completion15 Apr 2013

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 (1)Papers the sponsor has linked to this study.
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: Case only
Time perspective: Retrospective
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01805323
Sponsor's protocol ID: CMA-OZU-12-001
Status last verified: Apr 2019
First submitted: 5 Mar 2013
Last updated: 17 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lam WC, Albiani DA, Yoganathan P, Chen JC, Kherani A, Maberley DA, Oliver A, Rabinovitch T, Sheidow TG, Tourville E, Wittenberg LA, Sigouin C, Baptiste DC. Real-world assessment of intravitreal dexamethasone implant (0.7 mg) in patients with macular edema: the CHROME study. Clin Ophthalmol. 2015 Jul 10;9:1255-68. doi: 10.2147/OPTH.S80500. eCollection 2015.
PubMed 26203215

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)

All Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema
ClinicalTrials.gov ID: NCT01805323
Acronym / sponsor ID: CMA-OZU-12-001
Conditions: Macular Edema
Study type: Observational
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 1 Sep 2012 (actual)
Primary completion: 15 Apr 2013 (actual)
Study completion: 15 Apr 2013 (actual)
First posted: 6 Mar 2013 (estimated)
Results: Posted 30 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
All Participants	–	Drug: Dexamethasone Intravitreal ImplantPatients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with macular edema

Key inclusion criteria (2 listed)

Retinal disease involving macular edema
Received at least one OZURDEX® injection

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 ImplantAlso: OZURDEX®Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice.	Drug	All Participants

Primary outcome

Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
Time frame: Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 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 peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement.

1 secondary outcome

Peak Mean Change From Baseline in Central Retinal Thickness (CRT)
Time frame: Baseline, 2 to 26 weeks following last injection (up to 6.5 months)

Results and safety

Results posted to the registry on 30 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	101	101

Primary outcome: Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)

Time frame: Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months). Mean (Standard Error). Unit: Lines

Measure	All Participants n = 78
Baseline	6.3 (0.3)
Change from Baseline 2-26 wks after last injection	1.4 (0.3)

Population analysed: All participants with BCVA observations available following the last OZURDEX® injection from 2 to 26 weeks.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	4 of 101 (4%)	25 of 101 (24.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26203215Lam WC, Albiani DA, Yoganathan P, Chen JC, Kherani A, Maberley DA, Oliver A, Rabinovitch T, Sheidow TG, Tourville E, Wittenberg LA, Sigouin C, Baptiste DC. Real-world assessment of intravitreal dexamethasone implant (0.7 mg) in patients with macular edema: the CHROME study. Clin Ophthalmol. 2015 Jul 10;9:1255-68. doi: 10.2147/OPTH.S80500. eCollection 2015.

Related trials for Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)

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 Canada.

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 17 Apr 2019. 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 Canada. 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 30 May 2014). 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?

Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (time frame: Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 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 NCT01805323, which also lists 1 linked publication.

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 17 Apr 2019.