Thrombospondin-1 and Pigmented Epithelium Derived Factor Levels in Patients With Diabetes Mellitus. (PEDF)

February 17, 2017 updated by: MidAtlantic Retina

Modulation of Thrombospondin-1 and Pigment Epithelium Derived Factor Levels in Vitreous Fluid and Plasma of Patients With Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina- Wills Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 minutes and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Blood draw
Blood (approximately equal to 3 to 4 tablespoons) will be drawn at the Wills Eye Institute, 1 time.
Biological: Blood draw
3-4 tablespoons of blood will be drawn, one time.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MidAtlantic Retina

Investigators

  • Principal Investigator: Marc Spirn, M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 12, 2013

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-954
  • IRB# 09-954 (Other Identifier: Wills Eye Health System IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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