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

• Sponsor: MidAtlantic Retina (Other)
• Overall Status: Completed
• CT.gov ID: NCT01809093
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Duration (Months): 48
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Mar 1, 2010
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Level of thrombospondin (TSP1) and pigment epithelium derived factor (PEDF) in the vitreous and plasma [up to 6 months]

   Your voluntary participation in this study may help determine how different TSP1 and PEDF levels correlate with diabetic eye disease.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Minutes and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mid Atlantic Retina- Wills Eye Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• MidAtlantic Retina

Investigators

• Principal Investigator: Marc Spirn, M.D.,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MidAtlantic Retina, Principal Investigator, Wills Eye
• ClinicalTrials.gov Identifier: NCT01809093
• Other Study ID Numbers: 09-954; IRB# 09-954
• First Posted: Mar 12, 2013
• Last Update Posted: Feb 23, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by MidAtlantic Retina, Principal Investigator, 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: Diabetes Mellitus

Study Results

No Results Posted as of Feb 23, 2017