Epiretinal MembranePhase 2/3NCT01273727
Ozurdex for Macular Edema Post Membrane Peeling
A Phase 2/3 study testing Dexamethasone in people with Epiretinal Membrane and Cellophane Maculopathy, run by Retina Specialists, PC at 1 site in United States.
Trial summary
An epiretinal membrane is scar tissue on the retina that can cause blurring and distortion of vision and lead to swelling, or macular edema. Despite surgery to remove the scar tissue(membrane peeling), residual swelling of the retina may continue to interfere with vision. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Epiretinal Membrane, Cellophane Maculopathy, Macular Edema
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2014
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with macular edema who have had previous epi-retinal membrane peeling surgery for macular edema associated with epi-retinal membranes.
- All patients must have clear ocular media/lenses determined visually by the investigator in order to permit good quality stereoscopic fundus photography, fluorescein angiography and ocular coherence tomography.
Who cannot join
- Best corrected visual acuity 20/50 or better in the study eye
- Sub-macular hemorrhage in the study eye
- Sub-retinal fibrosis in the study eye
- Macular hole in the study eye
- Active inflammatory disease of the study eye
- Choroidal neovascularization in the study eye
Show all 11Show fewer
- History of other ophthalmic disorders with the exception of cataract or previous cataract extraction in the study eye
- Active ocular infection in the study eye
- Previous subfoveal laser treatment in the study eye
- Previous verteporfin photodynamic therapy in the study eye
- Any systemic medical condition that would preclude them from undergoing surgery with monitored sedation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ozurdex in Treatment of Macular Edema Post Membrane Peeling
An epiretinal membrane is scar tissue on the retina that can cause blurring and distortion of vision and lead to swelling, or macular edema. Despite surgery to remove the scar tissue(membrane peeling), residual swelling of the retina may continue to interfere with vision.
In this study the investigators will inject an implantable steroid device into the back, fluid-filled portion of the eye. Steroids have been found to decrease the swelling in the retina. Ozurdex™ is an implantable steroid. Once implanted, Ozurdex™ is slowly dissolved by the vitreous gel that fills the eye, releasing the steroid. The steroid drug delivery system in this study, known as Ozurdex™ has been FDA-approved by the US Food and Drug Administration (FDA) for decreasing swelling due to another condition in the eye. This study will help to find out whether or not this device Ozurdex™ is also effective for reducing the swelling of the retina in patients who have already had surgery to remove scar tissue on the retina.
- Being tested
- Dexamethasone
- Keywords
- epiretinal membrane, macular pucker, cellophane maculopathy, macular edema, retinal edema, ozurdex, dexamethasone, intravitreal implant
- Medical subject headings
- Epiretinal Membrane, Macular Edema, Papilledema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Ozurdex
intravitreal implant 0.7 mg 6 month duration
dexamethasoneDrug
Also called ozurdex
intravitreal implant 0.7 mg duration 6 months
| Study group | Role | What they receive |
|---|---|---|
| No Ozurdex | No intervention | Arm 1(control) - Patients who have had epi-retinal membrane peeling and have macular edema at least 3 months (90 days) after surgery. These patients will followed without Ozurdex. The patients will be treated with current standard of care, including topical and intravitreal or subtenon's medication. |
| Ozurdex 3 months after surgery | Experimental | Patients who have had epi-retinal membrane peeling and have residual macular edema 3 months after surgery. These patients will receive an Ozurdex implant Receives: Drug: Dexamethasone |
| Ozurdex 6 months or longer after surgery | Experimental | Patients who have had epiretinal membrane peeling and have residual macular edema at least 6 months after surgery Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment
Measured: 6 months
Secondary outcomes (1)
mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment
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 posted10 Jan 2011 (estimated)
- Study startJun 2010
- Primary completionApr 2014
- Study completionApr 2014
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Specialists, PC
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, John Khadem, Retina Specialists, PC
- Investigators
- John Khadem, MD, Principal investigator, Retina Specialists, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273727
- Sponsor's protocol ID
- 3433-001
- Status last verified
- May 2015
- First submitted
- 7 Jan 2011
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozurdex in Treatment of Macular Edema Post Membrane Peeling
- ClinicalTrials.gov ID
- NCT01273727
- Acronym / sponsor ID
- 3433-001
- Keywords
- epiretinal membrane, macular pucker, cellophane maculopathy, macular edema, retinal edema, ozurdex, dexamethasone, intravitreal implant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Retina Specialists, PCUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jun 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Jan 2011 (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.
An epiretinal membrane is scar tissue on the retina that can cause blurring and distortion of vision and lead to swelling, or macular edema. Despite surgery to remove the scar tissue(membrane peeling), residual swelling of the retina may continue to interfere with vision.
In this study the investigators will inject an implantable steroid device into the back, fluid-filled portion of the eye. Steroids have been found to decrease the swelling in the retina. Ozurdex™ is an implantable steroid. Once implanted, Ozurdex™ is slowly dissolved by the vitreous gel that fills the eye, releasing the steroid. The steroid drug delivery system in this study, known as Ozurdex™ has been FDA-approved by the US Food and Drug Administration (FDA) for decreasing swelling due to another condition in the eye. This study will help to find out whether or not this device Ozurdex™ is also effective for reducing the swelling of the retina in patients who have already had surgery to remove scar tissue on the retina.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Ozurdex | No intervention | –Arm 1(control) - Patients who have had epi-retinal membrane peeling and have macular edema at least 3 months (90 days) after surgery. These patients will followed without Ozurdex. The patients will be treated with current standard of care, including topical and intravitreal or subtenon's medication. |
| Ozurdex 3 months after surgery | Experimental | Drug: DexamethasonePatients who have had epi-retinal membrane peeling and have residual macular edema 3 months after surgery. These patients will receive an Ozurdex implant |
| Ozurdex 6 months or longer after surgery | Experimental | Drug: dexamethasonePatients who have had epiretinal membrane peeling and have residual macular edema at least 6 months after surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with macular edema who have had previous epi-retinal membrane peeling surgery for macular edema associated with epi-retinal membranes.
- All patients must have clear ocular media/lenses determined visually by the investigator in order to permit good quality stereoscopic fundus photography, fluorescein angiography and ocular coherence tomography.
Key exclusion criteria (11 listed)
- Best corrected visual acuity 20/50 or better in the study eye
- Sub-macular hemorrhage in the study eye
- Sub-retinal fibrosis in the study eye
- Macular hole in the study eye
- Active inflammatory disease of the study eye
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 |
|---|---|---|
| DexamethasoneAlso: Ozurdexintravitreal implant 0.7 mg 6 month duration | Drug | Ozurdex 3 months after surgery |
| dexamethasoneAlso: ozurdexintravitreal implant 0.7 mg duration 6 months | Drug | Ozurdex 6 months or longer after surgery |
Primary outcome
mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment
Time frame: 6 months
1 secondary outcome
mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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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.
John Khadem, MD principal investigator
Retina Specialists, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexamethasone in people with Epiretinal Membrane and Cellophane Maculopathy, run by Retina Specialists, PC 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 11 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 13 May 2015. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment (time frame: 6 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 13 May 2015.