The Effects of Intravitreal Ozurdex Implant in DME | NCT03475407

Studies
The Effects of Intravitreal Ozurdex Implant in DME

NCT03475407

Sponsor

Nune Eye Hospital, Seoul, Korea

Status

Unknown status

Last Update Posted

Mar 23, 2018Actual

Enrollment

20Estimated

Phase

Phase 4

Conditions

Diabetic Macular Edema

Interventions

Ozurdex intravitreal injection

Countries

South Korea

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015Actual

Primary Completion Date

Jun 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Apr 14, 2015

First Submission Date that Met QC Criteria

Mar 22, 2018

First Posted Date

Mar 23, 2018Actual

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

Mar 22, 2018

Last Update Posted Date

Mar 23, 2018Actual

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

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group	Experimental	Ozurdex intravitreal injection	Drug: Ozurdex intravitreal injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ozurdex intravitreal injection	Drug	Ozurdex intravitreal injection and Antreior Chamber(AC) paracentesis at baseline AC paracentesis at 6 wk intravitreal Ozurdex injection and AC paracentesis at 18wk or 24wk

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of Central foveal thickness(CFT, height in micrometers)		Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes of aqueous humor cytokine (VFGF, IL-2, IL-6,IL-8, MCP-1)		Baseline, 6 weeks, 18 weeks
Changes of Best corrected Visual acuity(BCVA, ETDRS scale)		Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:

Patients of Non Proliferative Diabetic Retinopathy(NPDR) with clinically significant macular edema(CSME)
Patients with Proliferative Diabetic Retinopathy(PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation
Diabetic patients with cystoids macular edema
Minimum central thickness on OCT not less than 300 microns
BCVA 20/30~20/320

Exclusion Criteria:

Patients with history of Anti-VEGF or steroid injection, any type of laser treatments, vitrectomy, cataract surgery within 6 months
Patients with history of ocular hypertension or glaucoma
Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT
Patients with macular ischemia on FFA
Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva
Patients whose posterior lens capsule is not intact.
patients with known hypersensitivity to any components of this product.
patients with vitreous hemorrhage
patients who have systemic treatment effect on study results
patients who enrolled other clinical study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic