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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01809093
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
MidAtlantic Retina, Wills Eye

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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus Biological: Blood draw

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.

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Modulation of Thrombospondin-1 and Pigment Epithelium Derived Factor Levels in Vitreous Fluid and Plasma of Patients With Diabetes
Study Start Date : March 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

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.




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
The level of TSP1 and PEDF in the vitreous and plasma.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diabetes mellitus who are undergoing pars plana vitrectomy for any reason
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809093


Locations
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United States, Pennsylvania
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
MidAtlantic Retina
Investigators
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Principal Investigator: Marc Spirn, M.D.

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Responsible Party: MidAtlantic Retina, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT01809093     History of Changes
Other Study ID Numbers: 09-954
IRB# 09-954 ( Other Identifier: Wills Eye Health System IRB )
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MidAtlantic Retina, Wills Eye:
PEDF
TSP1
Thrombospondin
pigment epithelium derived factor
Wills Eye Institute
Pars plana vitrectomy
Vitreous levels
Mid Atlantic Retina
Blood draw
Blood test

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
alpha-2-Antiplasmin
Pigment epithelium-derived factor
Serpins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants