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CompletedNCT01809093PEDFUpdated Feb 23, 2017

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

An observational study in Diabetes and Diabetes Mellitus, sponsored by MidAtlantic Retina. Completed at 1 site in United States. Open to participants aged 18 Minutes and older. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by MidAtlantic Retina · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
90
Ages
18 Minutes and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus

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Keywords

  • PEDF
  • TSP1
  • Thrombospondin
  • pigment epithelium derived factor
  • Wills Eye Institute
  • Pars plana vitrectomy
  • Vitreous levels
  • Mid Atlantic Retina
  • Blood draw
  • Blood test
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 90 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

MidAtlantic Retina is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Minutes and older
Sexes eligible
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

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

Exclusion Criteria:

  • Use of any anti-VEGF (vascular endothelial growth factor ) medications
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Blood draw

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

    Biological: Blood draw

Interventions

  • BiologicalBlood draw

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

06

What researchers measure

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.

    Time frame: up to 6 months

07

Study locations

1 site
  • Mid Atlantic Retina- Wills Eye Institute
    Philadelphia, Pennsylvania 19107, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01809093
Lead sponsor
MidAtlantic Retina
Responsible party
MidAtlantic Retina (Principal Investigator, Wills Eye) — Sponsor-investigator
First posted
Mar 12, 2013
Start date
Mar 2010
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Feb 23, 2017

Study contacts

Marc Spirn, M.D.
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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