Thrombospondin-1 and Pigmented Epithelium Derived Factor... | NCT01809093

Studies
Thrombospondin-1 and Pigmented Epithelium Derived Factor Levels in Patients With Diabetes Mellitus.

NCT01809093

Sponsor

MidAtlantic Retina

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus

Interventions

Blood draw

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

ID	Type	Description	Link
IRB# 09-954	Other Identifier	Wills Eye Health System IRB

Status Module

Record Verification Date

Feb 2017

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

Mar 2010

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Mar 7, 2013

First Submission Date that Met QC Criteria

Mar 7, 2013

First Posted Date

Mar 12, 2013Estimated

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

Feb 17, 2017

Last Update Posted Date

Feb 23, 2017Actual

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

You are being asked to be in a research study to determine blood levels and vitreous levels of compounds called thrombospondin 1 (TSP1) and pigment epithelium derived factor (PEDF). These compounds exists naturally in your body.

Detailed Description

The hypothesis tested here is that diabetic patients that express the higher molecular weight pigment epithelium-derived factor (PEDF) isoform have lower thrombospondin-1 (TSP1) level and, as a result, are at a greater risk for the development of more severe diabetic retinopathy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Blood draw		Blood (approximately equal to 3 to 4 tablespoons) will be drawn at the Wills Eye Institute, 1 time.	Biological: Blood draw

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood draw	Biological	3-4 tablespoons of blood will be drawn, one time.	Blood draw

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of thrombospondin (TSP1) and pigment epithelium derived factor (PEDF) in the vitreous and plasma	Your voluntary participation in this study may help determine how different TSP1 and PEDF levels correlate with diabetic eye disease.	up to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study
Diabetes Mellitus
Undergoing pars plana vitrectomy for any reason

Exclusion Criteria:

Use of any anti-VEGF (vascular endothelial growth factor ) medications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Minutes

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with diabetes mellitus who are undergoing pars plana vitrectomy for any reason

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Spirn, M.D.		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mid Atlantic Retina- Wills Eye Institute		Philadelphia	Pennsylvania	19107	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided