Increase in Capillary Plexus Density Level Following the... | NCT04038125

Studies
Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME

NCT04038125

Sponsor

Retina Macula Specialists of Miami, LLC

Status

Unknown status

Last Update Posted

Mar 18, 2020Actual

Enrollment

20Estimated

Phase

Phase 4

Conditions

Diabetic Macular Edema
Diabetic Retinopathy
Retinal Ischemia

Interventions

Ozurdex Drug Implant Product

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

Mar 2020

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

Aug 22, 2019Actual

Primary Completion Date

Aug 2020Estimated

Completion Date

Aug 2021Estimated

First Submitted Date

Jul 26, 2019

First Submission Date that Met QC Criteria

Jul 29, 2019

First Posted Date

Jul 30, 2019Actual

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 16, 2020

Last Update Posted Date

Mar 18, 2020Actual

Name	Class
Allergan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to test the hypothesis that following the use of intravitreal dexamethasone implant for the treatment of DME, there will be an observable increase in the capillary density plexus as denoted by the quantitative assessment of the superficial capillary plexus on OCTA, as well as a decrease in size of the foveal avascular zone (FAZ).

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 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
Ozurdex Implant	Other	Intravitreal injection of Ozurdex implant	Drug: Ozurdex Drug Implant Product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ozurdex Drug Implant Product	Drug	Intravitreal Ozurdex injection	Ozurdex Implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate re perfusion following Ozurdex use.	Determined by OCT-A	6 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years and Older.
Diagnosis of diabetes mellitus (type 1 or type 2).
At least one eye meets the study eye criteria listed.
Visual Acuity 20/30 - 20/200 Snellen equivalent
Have received no previous treatment for diabetic macular edema,(treatment naïve)
Mild to Severe Non-proliferative Diabetic Retinopathy
Diabetic macular edema present on optical coherence tomography (OCT) central subfield: ≥ 300µm.
Able and willing to provide informed consent.

Exclusion Criteria:

Have had any prior ocular treatment.
Have had prior retinal surgical ( i.e. Pars plana vitrectomy). 3 .Have any clinical evidence of proliferative diabetic retinopathy.

4. Have a HBA1c of greater of 10%. 5. Evidence of Glaucoma or who are labeled glaucoma suspect at screening (defined as C/D >/= 0.5 with correlated NFLA thinning or IOP>25mmHg). 6. Have a contraindication to Ozurdex.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

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

Name	Role	Phone	Extension	Email
Diana Shechtman, OD FAAO	Contact	954-816-1038		dshehctman@retinamiami.com
Pamela Garcia, CCRC	Contact	305-643-8871		pjimenez@retinamiami.com

Overall Officials

Name	Affiliation	Role
Diana Shechtman, OD FAAO	Retina Macula Specialists of Miami, LLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Retina Macula Specialists of Miami, LLC	Recruiting	North Miami Beach	Florida	33162	United States

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular 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