Diabetic Macular EdemaPhase 4OPERANCT01613716
Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)
A Phase 4 study testing Ozurdex in people with Diabetic Macular Edema and Epiretinal Membrane, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study will examine the use of the dexamethasone implant (Ozurdex) in patients with macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will be placed in the eye. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Macular Edema, Epiretinal Membrane
- What is being tested?
- Ozurdex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Feb 2017
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are undergoing pars plana vitrectomy for:
- Epiretinal membrane/vitreomacular traction or
- Diabetic macular edema
- Patients with macular edema as measured by OCT (at least 250 um central subfoveal thickness)
- Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English.
- Age between 18-85 years old
Who cannot join
- Age < 18 years or > 85 years
- History of macular edema due to diseases other than those in the inclusion criteria in the study eye
- History of active inflammatory eye disease (uveitis) (within 3 months)
- History of ocular malignancy and/or ocular/orbital irradiation
- History of recent retinal vein occlusion (within 6 months)
- History of neovascular age-related macular degeneration or choroidal neovascular membrane [
Show all 16Show fewer
- History of juxtafoveal telangiectasia
- History of Coat's disease
- History central serous choroidoretinopathy
- History of previous infectious retinitis (toxoplasmosis, acute retinal necrosis, tuberculosis, etc)
- Patients with a history of intraocular infection in the study eye (i.e. viral retinitis, endophthalmitis)
- Patients who are cognitively impaired or those who are unable to provide informed written consent
- Patients with a history of glaucoma in the study eye (defined as increased cup to disc ratio with associated nerve damage. Patients with ocular hypertension controlled by topical glaucoma drops (maximum 3) will not be excluded).
- Patient with recent intravitreal injections of steroids or anti-VEGF medications in the study eye (within past 4 weeks).
- Patients with recent periocular steroid injection (within past 4 weeks) in the study eye
- Patients on topical NSAIDS drops (patient will be eligible if they discontinue use of topical NSAIDs at time of study enrollment) in the study eye
Trial locations and contacts
1 site in 1 country.
United States1 site
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, 44195
About this study
This study will examine the use of the dexamethasone implant (Ozurdex) in patients with macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will be placed in the eye. Patients will be followed for 1 year.
Read the detailed description
The purpose of this study to examine the use of Ozurdex in patients who are undergoing pars plana vitrectomy for macular edema due to preretinal membranes. Specifically, we will examine its effect on macular edema (measured by OCT), and visual recovery (measured by visual acuity). We will examine its use in patients who underwent pars plana vitrectomy for macular edema with associated taut membrane. This will be a prospective pilot study with patients to receive an Ozurdex implant at the time of vitrectomy.
- Conditions
- Diabetic Macular Edema, Epiretinal Membrane
- Being tested
- Ozurdex
- Keywords
- Diabetes, Macular Edema, Epiretinal Membrane, Vitrectomy
- Medical subject headings
- Epiretinal Membrane, Diabetes Mellitus, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzurdexDrug
Also called Dexamethasone
Ozurdex .7 mg injected into the treated eye
| Study group | Role | What they receive |
|---|---|---|
| Ozurdex | Experimental | Subjects will receive Ozurdex injections and will be monitored for macular edema. Receives: Drug: Ozurdex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Retinal Thickness
At 3 months, central retinal thickness as measured by optical coherence tomography will be measured
Measured: 3 months
Visual Acuity
ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2016
- Study completionFeb 2017
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 Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Sunil Srivastava, The Cleveland Clinic
- Investigators
- Sunil Srivastava, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613716
- Sponsor's protocol ID
- 115200
- Acronym
- OPERA
- Status last verified
- Apr 2018
- First submitted
- 5 Jun 2012
- Last updated
- 16 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)
- ClinicalTrials.gov ID
- NCT01613716
- Acronym / sponsor ID
- OPERA / 115200
- Conditions
- Diabetic Macular Edema, Epiretinal Membrane
- Keywords
- Diabetes, Macular Edema, Epiretinal Membrane, Vitrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jul 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Posted 16 May 2018
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 examine the use of the dexamethasone implant (Ozurdex) in patients with macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will be placed in the eye. Patients will be followed for 1 year.
Detailed description
The purpose of this study to examine the use of Ozurdex in patients who are undergoing pars plana vitrectomy for macular edema due to preretinal membranes. Specifically, we will examine its effect on macular edema (measured by OCT), and visual recovery (measured by visual acuity). We will examine its use in patients who underwent pars plana vitrectomy for macular edema with associated taut membrane. This will be a prospective pilot study with patients to receive an Ozurdex implant at the time of vitrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ozurdex | Experimental | Drug: OzurdexSubjects will receive Ozurdex injections and will be monitored for macular edema. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are undergoing pars plana vitrectomy for:
- Patients with macular edema as measured by OCT (at least 250 um central subfoveal thickness)
- Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English.
- Age between 18-85 years old
Key exclusion criteria (16 listed)
- Age < 18 years or > 85 years
- History of macular edema due to diseases other than those in the inclusion criteria in the study eye
- Patients with a history of intraocular infection in the study eye (i.e. viral retinitis, endophthalmitis)
- Patients who are cognitively impaired or those who are unable to provide informed written consent
- Patients with a history of glaucoma in the study eye (defined as increased cup to disc ratio with associated nerve damage. Patients with ocular hypertension controlled by topical glaucoma drops (maximum 3) will not be excluded).
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: DexamethasoneOzurdex .7 mg injected into the treated eye | Drug | Ozurdex |
Primary outcome
Central Retinal Thickness
Time frame: 3 months
At 3 months, central retinal thickness as measured by optical coherence tomography will be measured
Visual Acuity
Time frame: 3 months
ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sunil Srivastava, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ozurdex in people with Diabetic Macular Edema and Epiretinal Membrane, run by The Cleveland Clinic 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 6 inclusion and 16 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 May 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2018). 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?
Central Retinal Thickness (time frame: 3 months). The study lists 2 primary outcomes in all. 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 16 May 2018.