Diabetic RetinopathyNCT00005761
Blood Factors and Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This study will determine whether certain factors in the blood are associated with the severity of diabetic retinopathy. Patients age 10 years and older with diabetes mellitus and diabetic retinopathy may be eligible for this study. Those enrolled will represent a range of diabetic retinopathy from minimal to severe. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2000to 7 Dec 2010
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Neither volunteers nor participants will be eligible if they:
- Are under the age of 10.
- Have severe systemic disease(s) that compromise our ability to obtain an adequate examination.
- Have any of the following ocular characteristics or conditions in both eyes:
- Opacities of the ocular media, limitations or pupillary dilation or any other problems sufficient to preclude good, quality stereo fundus photographs.
- Ocular disease which confounds assessment of diabetic retinopathy such as advanced age-related macular degeneration, central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration.
- Chronic requirement for any ocular medication for other diseases, such as glaucoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Study of Association of Serum Factors With Diabetic Retinopathy
This study will determine whether certain factors in the blood are associated with the severity of diabetic retinopathy.
Patients age 10 years and older with diabetes mellitus and diabetic retinopathy may be eligible for this study. Those enrolled will represent a range of diabetic retinopathy from minimal to severe. Participants will undergo the following procedures:
Read more
- medical history
- thorough eye examination
- photographs of the eye
- blood tests to measure blood lipids (cholesterol and triglycerides) and serum creatinine (for kidney function)
- blood tests to measure levels of blood factors (cell adhesion molecules, chemokines and vascular endothelial growth factor) that may be related to the progression of diabetic retinopathy
- blood pressure measurement
- urinalysis
This study may lead to a better understanding of how diabetic retinopathy develops and progresses.
Read the detailed description
Participants with a range of severity of diabetic retinopathy and healthy volunteers will be evaluated once for serum levels of cell adhesion molecules, chemokines and vascular endothelial growth factor. This study may lead to a better understanding of the pathogenesis of diabetic retinopathy and the identifying of possible targets for treatment. All study participants will undergo an ocular exam and ophthalmic photography. Blood is drawn for the analysis of these serum factors.
- Conditions
- Diabetic Retinopathy
- Keywords
- Types 1 & 2 Diabetes, Cell Adhesion Molecules, Chemokines, Vascular Endothelial Growth Factor, Cross-Sectional, Serum Levels, Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2000 (estimated)
- Study start23 May 2000
- Study completion7 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies 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
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005761
- Sponsor's protocol ID
- 000135
- Other IDs
- 00-EI-0135
- Status last verified
- 7 Dec 2010
- First submitted
- 26 May 2000
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Winocour PD. Platelet abnormalities in diabetes mellitus. Diabetes. 1992 Oct;41 Suppl 2:26-31. doi: 10.2337/diab.41.2.s26.
PubMed 1526332Lupu C, Calb M, Ionescu M, Lupu F. Enhanced prothrombin and intrinsic factor X activation on blood platelets from diabetic patients. Thromb Haemost. 1993 Oct 18;70(4):579-83.
PubMed 8115982Jaffe EA. Cell biology of endothelial cells. Hum Pathol. 1987 Mar;18(3):234-9. doi: 10.1016/s0046-8177(87)80005-9.
PubMed 3546072
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Association of Serum Factors With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT00005761
- Acronym / sponsor ID
- 000135
- Conditions
- Diabetic Retinopathy
- Keywords
- Types 1 & 2 Diabetes, Cell Adhesion Molecules, Chemokines, Vascular Endothelial Growth Factor, Cross-Sectional, Serum Levels, Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 23 May 2000
- Study completion
- 7 Dec 2010
- First posted
- 29 May 2000 (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.
This study will determine whether certain factors in the blood are associated with the severity of diabetic retinopathy.
Patients age 10 years and older with diabetes mellitus and diabetic retinopathy may be eligible for this study. Those enrolled will represent a range of diabetic retinopathy from minimal to severe. Participants will undergo the following procedures:
- medical history
- thorough eye examination
- photographs of the eye
- blood tests to measure blood lipids (cholesterol and triglycerides) and serum creatinine (for kidney function)
- blood tests to measure levels of blood factors (cell adhesion molecules, chemokines and vascular endothelial growth factor) that may be related to the progression of diabetic retinopathy
- blood pressure measurement
- urinalysis
This study may lead to a better understanding of how diabetic retinopathy develops and progresses.
Detailed description
Participants with a range of severity of diabetic retinopathy and healthy volunteers will be evaluated once for serum levels of cell adhesion molecules, chemokines and vascular endothelial growth factor. This study may lead to a better understanding of the pathogenesis of diabetic retinopathy and the identifying of possible targets for treatment. All study participants will undergo an ocular exam and ophthalmic photography. Blood is drawn for the analysis of these serum factors.
Study design
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Are under the age of 10.
- Have severe systemic disease(s) that compromise our ability to obtain an adequate examination.
- Have any of the following ocular characteristics or conditions in both eyes:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 1526332Winocour PD. Platelet abnormalities in diabetes mellitus. Diabetes. 1992 Oct;41 Suppl 2:26-31. doi: 10.2337/diab.41.2.s26.
- Background: PubMed 8115982Lupu C, Calb M, Ionescu M, Lupu F. Enhanced prothrombin and intrinsic factor X activation on blood platelets from diabetic patients. Thromb Haemost. 1993 Oct 18;70(4):579-83.
- Background: PubMed 3546072Jaffe EA. Cell biology of endothelial cells. Hum Pathol. 1987 Mar;18(3):234-9. doi: 10.1016/s0046-8177(87)80005-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetic Retinopathy, run by National Eye Institute (NEI) 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 0 inclusion and 7 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 2 Jul 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005761, which also lists 3 linked publications.
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 2 Jul 2017.