Epiretinal MembraneNCT01701518
A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes
A study testing Ozurdex in people with Epiretinal Membrane and Macular Edema, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial summary
To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as demonstrated by a gain in vision and decreased in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epiretinal Membrane, Macular Edema
- What is being tested?
- Ozurdex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing vitrectomy surgery for a visually significant (≤ 20/50) idiopathic epiretinal membrane.
- Central retinal thickness ≥ 250 μm.
- Age more than 18 years old.
- Decision makers able to give informed consent.
- Females of child bearing potential must agree to use acceptable means of birth control for the duration of the study.
Who cannot join
- Secondary epiretinal membranes (ex: secondary to a retinal vein occlusion, etc.).
- Any other macular pathology that could affect anatomic or functional results.
- History of uveitis requiring intravitreal triamcinolone injection.
- History of steroid-responsive glaucoma.
- History of moderate or advanced glaucoma (cup to disc ratio ≥ 0.7).
- IOP > 23 mm Hg if untreated, or > 21 mm Hg if treated with medication.
Show all 10Show fewer
- Pregnant or breast-feeding woman.
- Unable to attend the scheduled follow-up appointments.
- Patients with known hypersensitivity to any components of Ozurdex® or to other corticosteroids.
- Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Charlene Muller, 416-480-5091, charlene.muller@sunnybrook.ca
Peter J Kertes, MD,CM,FRCSC
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5C 2T2
Rajeev Muni, MD, FRCSC, (416) 867-7422, rajeev.muni@utoronto.ca
Rajeev Muni, MD,FRCSC
About this study
Official title: A Prospective Multicentre Pilot Study of the Effectiveness of an Intra-operative Intravitreal Sustained Release Dexamethasone Implant (Ozurdex®) in Vitrectomy Surgery for Epiretinal Membranes
To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as demonstrated by a gain in vision and decreased in retinal thickness and volume.
Read the detailed description
We believe that the use of intravitreal corticosteroids post-operatively has the capacity to mitigate much of the residual swelling and retinal thickening that is seen after vitrectomy for epiretinal membranes. The unique pharmacokinetics of the sustained released dexamethasone implant (Ozurdex®) makes it an ideal delivery system to use post-vitrectomy for epiretinal membrane surgery. Its duration of action and its drug delivery characteristics over 6 months approximately match the post-operative time course of healing and remodeling in an edematous retina.
This is a prospective, multicentre, pilot study evaluating the efficacy of an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in 15 patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes.
- Conditions
- Epiretinal Membrane, Macular Edema
- Being tested
- Ozurdex
- Keywords
- Ozurdex, Dexamethasone, Epiretinal membrane, Macular edema
- Medical subject headings
- Epiretinal Membrane, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzurdexDrug
Also called 0.7mg dexamethasone implant
biodegradable 0.7mg dexamethasone implant
| Study group | Role | What they receive |
|---|---|---|
| Ozurdex | Other | Intra-operative Ozurdex (biodegradable 0.7mg dexamethasone implant) post-vitrectomy for epiretinal membrane Receives: Drug: Ozurdex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.
Measured: 3 Months
Secondary outcomes (4)
Best corrected visual acuity at 1,4 and 6 months
Best corrected visual acuity measured at 1,4 and 6 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.
Measured: 6 months
Retinal thickness and volume
Measure the change in retinal thickness and volume from baseline and at 1, 3, 4, 6 months using optical coherence tomography (OCT).
Measured: 6 months
Intraocular pressure (IOP)
Change of IOP from baseline will be monitored.
Measured: 6 months
Cataract progression (if applicable)
For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, Allergan
- Responsible party
- Sponsor
- Investigators
- Peter J Kertes, MD,CM,FRCSC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701518
- Sponsor's protocol ID
- OZ123
- Other IDs
- OZ123
- Status last verified
- Jan 2016
- First submitted
- 3 Oct 2012
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentre Pilot Study of the Effectiveness of an Intra-operative Intravitreal Sustained Release Dexamethasone Implant (Ozurdex®) in Vitrectomy Surgery for Epiretinal Membranes
- ClinicalTrials.gov ID
- NCT01701518
- Acronym / sponsor ID
- OZ123
- Conditions
- Epiretinal Membrane, Macular Edema
- Keywords
- Ozurdex, Dexamethasone, Epiretinal membrane, Macular edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Unity Health Toronto, Allergan
- Study start
- Oct 2012
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as demonstrated by a gain in vision and decreased in retinal thickness and volume.
Detailed description
We believe that the use of intravitreal corticosteroids post-operatively has the capacity to mitigate much of the residual swelling and retinal thickening that is seen after vitrectomy for epiretinal membranes. The unique pharmacokinetics of the sustained released dexamethasone implant (Ozurdex®) makes it an ideal delivery system to use post-vitrectomy for epiretinal membrane surgery. Its duration of action and its drug delivery characteristics over 6 months approximately match the post-operative time course of healing and remodeling in an edematous retina.
This is a prospective, multicentre, pilot study evaluating the efficacy of an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in 15 patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ozurdex | Other | Drug: OzurdexIntra-operative Ozurdex (biodegradable 0.7mg dexamethasone implant) post-vitrectomy for epiretinal membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing vitrectomy surgery for a visually significant (≤ 20/50) idiopathic epiretinal membrane.
- Central retinal thickness ≥ 250 μm.
- Age more than 18 years old.
- Decision makers able to give informed consent.
- Females of child bearing potential must agree to use acceptable means of birth control for the duration of the study.
Key exclusion criteria (10 listed)
- Secondary epiretinal membranes (ex: secondary to a retinal vein occlusion, etc.).
- Any other macular pathology that could affect anatomic or functional results.
- History of uveitis requiring intravitreal triamcinolone injection.
- History of steroid-responsive glaucoma.
- History of moderate or advanced glaucoma (cup to disc ratio ≥ 0.7).
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 |
|---|---|---|
| OzurdexAlso: 0.7mg dexamethasone implantbiodegradable 0.7mg dexamethasone implant | Drug | Ozurdex |
Primary outcome
Best corrected visual acuity
Time frame: 3 Months
Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.
4 secondary outcomes
Best corrected visual acuity at 1,4 and 6 months
Time frame: 6 months
Retinal thickness and volume
Time frame: 6 months
Intraocular pressure (IOP)
Time frame: 6 months
Cataract progression (if applicable)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
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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.
Peter J Kertes, MD,CM,FRCSC principal investigator
Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozurdex in people with Epiretinal Membrane and Macular Edema, run by Sunnybrook Health Sciences Centre at 2 sites 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlene Muller (416-480-5091, charlene.muller@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: 3 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 5 Jan 2016.