Ozurdex for Combined Pseudophakic Cystoid Macular Edema a... | NCT01284478

Studies
Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery

NCT01284478

Sponsor

Northern California Retina Vitreous Associates

Status

Completed

Last Update Posted

Oct 4, 2012Estimated

Enrollment

6Actual

Phase

Phase 2

Conditions

Pseudophakic Cystoid Macular Edema,
Diabetic Macular Edema

Interventions

Dexamethasone Implant

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

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

Jan 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Jan 25, 2011

First Submission Date that Met QC Criteria

Jan 25, 2011

First Posted Date

Jan 27, 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

Oct 3, 2012

Last Update Posted Date

Oct 4, 2012Estimated

Name	Class
Allergan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexamethasone Implant	Other	Patients will be treated with the Ozurdex (Dexamethasone Implant)	Drug: Dexamethasone Implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone Implant	Drug	Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally	Dexamethasone Implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BEST CORRECTED VISUAL ACUITY (ETDRS)		AT DAY 180

Secondary Outcomes

Measure	Description	Time Frame
RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY	CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME	90 and 180 DAYS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DIABETIC PATIENTS WHO DEVELOP CYSTOID MACULA EDEMA AFTER CATARACT SURGERY (WITHIN 4-10 WEEKS AFTER SURGERY
VISUAL ACUITY WORSE THAN 20/32

Exclusion Criteria:

VISUAL ACUITY WORSE THAN 20/200
MODERATE OR SEVERE GLAUCOMA (AS DEFINED AS USING >2 TOPICAL GLAUCOMA MEDIATIONS.
USE OF SYSTEMIC, PERIOCULAR OR INTRAOCULAR CORTICOSTEROIDS WITHIN 30 DAYS OF ENROLLMENT

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rahul Khurana, MD	Northern California Retina Vitreous Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northern California Retina Vitreous Associates		Mountain View	California	94040	United States

Type	Date	Date Unknown
Release	Feb 16, 2015
Reset	Feb 28, 2015
Release	Mar 10, 2015
Reset	Mar 20, 2015
Release	Feb 1, 2019
Reset	Feb 1, 2019

Submission Tracking

Estimated Results First Submitted Date

Feb 16, 2015

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 16, 2015			Feb 28, 2015
Mar 10, 2015

Condition Browse Module

MeSH Terms

ID	Term
D008269	Macular Edema

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided