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

Diabetes Clinical Trial

— PEDF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809093
• Other study ID #: 09-954
• Secondary ID: IRB# 09-954
• Status: Completed
• Phase: N/A
• First received: March 7, 2013
• Last updated: February 17, 2017
• Start date: March 2010
• Est. completion date: March 2014

Study information

• Verified date: February 2017
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Biological:
• Blood draw
3-4 tablespoons of blood will be drawn, one time.

Locations

Country	Name	City	State
United States	Mid Atlantic Retina- Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
MidAtlantic Retina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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