NCT01809093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

4 years

First QC Date

March 7, 2013

Last Update Submit

February 17, 2017

Conditions

DiabetesDiabetes Mellitus

Keywords

PEDFTSP1Thrombospondinpigment epithelium derived factorWills Eye InstitutePars plana vitrectomyVitreous levelsMid Atlantic RetinaBlood drawBlood test

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Blood draw

Blood (approximately equal to 3 to 4 tablespoons) will be drawn at the Wills Eye Institute, 1 time.

Biological: Blood draw

Interventions

Blood drawBIOLOGICAL

3-4 tablespoons of blood will be drawn, one time.

Blood draw

Eligibility Criteria

Age18 Minutes+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mid Atlantic Retina- Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The level of TSP1 and PEDF in the vitreous and plasma.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Marc Spirn, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 12, 2013

Study Start

March 1, 2010

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)