DiabetesPEDFNCT01809093
Thrombospondin-1 and Pigmented Epithelium Derived Factor Levels in Patients With Diabetes Mellitus.
An observational study of Diabetes and Diabetes Mellitus, run by MidAtlantic Retina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 minutes and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus
- What is being tested?
- Blood draw
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 minutes and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diabetes mellitus who are undergoing pars plana vitrectomy for any reason
Who may be able to join
- 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
Who cannot join
- Use of any anti-VEGF (vascular endothelial growth factor ) medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
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.
- Conditions
- Diabetes, Diabetes Mellitus
- Being tested
- Blood draw
- Keywords
- PEDF, TSP1, Thrombospondin, pigment epithelium derived factor, Wills Eye Institute, Pars plana vitrectomy, Vitreous levels, Mid Atlantic Retina, Blood draw, Blood test
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawBiological
3-4 tablespoons of blood will be drawn, one time.
| Study group | Role | What they receive |
|---|---|---|
| Blood draw | Blood (approximately equal to 3 to 4 tablespoons) will be drawn at the Wills Eye Institute, 1 time. Receives: Biological: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startMar 2010
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- MidAtlantic Retina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MidAtlantic Retina, Wills Eye
- Investigators
- Marc Spirn, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809093
- Sponsor's protocol ID
- 09-954
- Other IDs
- IRB# 09-954
- Acronym
- PEDF
- Status last verified
- Feb 2017
- First submitted
- 7 Mar 2013
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Thrombospondin-1 and Pigment Epithelium Derived Factor Levels in Vitreous Fluid and Plasma of Patients With Diabetes
- ClinicalTrials.gov ID
- NCT01809093
- Acronym / sponsor ID
- PEDF / 09-954
- Conditions
- Diabetes, Diabetes Mellitus
- Keywords
- PEDF, TSP1, Thrombospondin, pigment epithelium derived factor, Wills Eye Institute, Pars plana vitrectomy, Vitreous levels, Mid Atlantic Retina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- MidAtlantic RetinaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood draw | – | Biological: Blood drawBlood (approximately equal to 3 to 4 tablespoons) will be drawn at the Wills Eye Institute, 1 time. |
Who may qualify
- Ages
- 18 minutes and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diabetes mellitus who are undergoing pars plana vitrectomy for any reason
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Use of any anti-VEGF (vascular endothelial growth factor ) medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw3-4 tablespoons of blood will be drawn, one time. | Biological | Blood draw |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Spirn, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, run by MidAtlantic Retina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of thrombospondin (TSP1) and pigment epithelium derived factor (PEDF) in the vitreous and plasma (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.