Ozurdex for Macular Edema Post Membrane Peeling | NCT01273727

Studies
Ozurdex for Macular Edema Post Membrane Peeling

NCT01273727

Sponsor

Retina Specialists, PC

Status

Completed

Last Update Posted

May 13, 2015Estimated

Enrollment

35Actual

Phase

Phase 2Phase 3

Conditions

Epiretinal Membrane
Cellophane Maculopathy
Macular Edema
Retinal Edema

Interventions

Dexamethasone
dexamethasone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jan 7, 2011

First Submission Date that Met QC Criteria

Jan 7, 2011

First Posted Date

Jan 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2015

Last Update Posted Date

May 13, 2015Estimated

Name	Class
Allergan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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	Drug: dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	intravitreal implant 0.7 mg 6 month duration	Ozurdex 3 months after surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment		6 months

Secondary Outcomes

Measure	Description	Time Frame
mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria:

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
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
John Khadem, MD	Retina Specialists, PC	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Retina Specialists PC		New York	New York	10011	United States

Condition Browse Module

MeSH Terms

ID	Term
D019773	Epiretinal Membrane
D008269	Macular Edema
D010211	Papilledema

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D008268	Macular Degeneration
D012162	Retinal Degeneration

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D002123	Calcium Dobesilate

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided