Diabetic RetinopathyNCT00712842
Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy
An observational study of Diabetic Retinopathy, run by Gerhard Garhofer at 1 site in Austria.
Trial summary
A variety of studies demonstrate that ocular blood flow is altered in diabetes and retinal perfusion abnormalities have been proposed to contribute to the pathogenesis of diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Ocular blood flow measurements
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2007to Dec 2011
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 50 Patients with Diabetes Type 1 50 Healthy Control Subjects
Who may be able to join
- Men and women aged between 20 and 50 years
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Inclusion criteria of patients are insulin dependent diabetes mellitus (IDDM) with non or mild non-proliferative retinopathy. Patients with no signs of diabetic retinopathy (level 1) or patients with one or more microaneurysms (level 2) will be included. Duration of Diabetes is between 5 and 20 years
- Men and women will be included in equal parts. A pregnancy test will be performed at screening
- Ametropia of less than 3 diopters and anisometropia of less than 1 diopter
Who cannot join
- Non insulin dependent diabetes
- Maturity onset diabetes of the young (MODY diabetes)
- Any sign of non diabetes induced vascular pathologies, systemic hypertension (defined as systolic blood pressure > 150 mm Hg and diastolic blood pressure > 90 mm Hg.)
- Presence of intraocular pathology other than diabetic retinopathy
- History or family history of epilepsy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
A variety of studies demonstrate that ocular blood flow is altered in diabetes and retinal perfusion abnormalities have been proposed to contribute to the pathogenesis of diabetic retinopathy.
Various animal and human studies have demonstrated that retinal and optic nerve blood flow increase in response to diffuse luminance flicker. Based on studies with ERG, this effect has been attributed to augmented activity in the retinal ganglion cells and associated axons indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a variety of studies describe the effects of flickering light on retinal and optic nerve head blood flow, the knowledge about this coupling in the diabetic retina is sparse.
In view of the fact that neural activity and blood flow are strongly coupled in the human retina, one could hypothesize that neurodegenerative changes in the retina could contribute to the vascular dysregulation and in turn lead to changes of ocular perfusion. The investigators set out to investigate whether the coupling of neural activity and blood flow is impaired in patients with early stage diabetic retinopathy compared to those in healthy volunteers.
- Conditions
- Diabetic Retinopathy
- Being tested
- Ocular blood flow measurements
- Keywords
- Diabetes, ocular blood flow
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular blood flow measurementsOther
non-invasive haemodynamic measurements of retinal vessel diameters and laser Doppler velocimetry
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with non or mild non-proliferative diabetic retinopathy Receives: Other: Ocular blood flow measurements | |
| 2 | Healthy control subjects Receives: Other: Ocular blood flow measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measured: 90 minutes
Retinal arterial and venous diameter
Measured: 90 minutes
Retinal blood velocity
Measured: 90 minutes
Pattern ERG
Measured: measured once on the study day
Secondary outcomes (2)
Mean arterial pressure
Measured: 90 minutes
Blood glucose
Measured: measured once on the study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startJan 2007
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerhard Garhofer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712842
- Sponsor's protocol ID
- OPHT-221203
- Status last verified
- Jul 2012
- First submitted
- 7 Jul 2008
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lasta M, Pemp B, Schmidl D, Boltz A, Kaya S, Palkovits S, Werkmeister R, Howorka K, Popa-Cherecheanu A, Garhofer G, Schmetterer L. Neurovascular dysfunction precedes neural dysfunction in the retina of patients with type 1 diabetes. Invest Ophthalmol Vis Sci. 2013 Jan 30;54(1):842-7. doi: 10.1167/iovs.12-10873.
PubMed 23307962
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy
- ClinicalTrials.gov ID
- NCT00712842
- Acronym / sponsor ID
- OPHT-221203
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetes, ocular blood flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gerhard GarhoferUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Jul 2008 (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.
A variety of studies demonstrate that ocular blood flow is altered in diabetes and retinal perfusion abnormalities have been proposed to contribute to the pathogenesis of diabetic retinopathy.
Various animal and human studies have demonstrated that retinal and optic nerve blood flow increase in response to diffuse luminance flicker. Based on studies with ERG, this effect has been attributed to augmented activity in the retinal ganglion cells and associated axons indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a variety of studies describe the effects of flickering light on retinal and optic nerve head blood flow, the knowledge about this coupling in the diabetic retina is sparse.
In view of the fact that neural activity and blood flow are strongly coupled in the human retina, one could hypothesize that neurodegenerative changes in the retina could contribute to the vascular dysregulation and in turn lead to changes of ocular perfusion. The investigators set out to investigate whether the coupling of neural activity and blood flow is impaired in patients with early stage diabetic retinopathy compared to those in healthy volunteers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Ocular blood flow measurementsPatients with non or mild non-proliferative diabetic retinopathy |
| 2 | – | Other: Ocular blood flow measurementsHealthy control subjects |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 50 Patients with Diabetes Type 1 50 Healthy Control Subjects
Key inclusion criteria (5 listed)
- Men and women aged between 20 and 50 years
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Inclusion criteria of patients are insulin dependent diabetes mellitus (IDDM) with non or mild non-proliferative retinopathy. Patients with no signs of diabetic retinopathy (level 1) or patients with one or more microaneurysms (level 2) will be included. Duration of Diabetes is between 5 and 20 years
- Men and women will be included in equal parts. A pregnancy test will be performed at screening
- Ametropia of less than 3 diopters and anisometropia of less than 1 diopter
Key exclusion criteria (6 listed)
- Non insulin dependent diabetes
- Maturity onset diabetes of the young (MODY diabetes)
- Any sign of non diabetes induced vascular pathologies, systemic hypertension (defined as systolic blood pressure > 150 mm Hg and diastolic blood pressure > 90 mm Hg.)
- Presence of intraocular pathology other than diabetic retinopathy
- History or family history of epilepsy
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 |
|---|---|---|
| Ocular blood flow measurementsnon-invasive haemodynamic measurements of retinal vessel diameters and laser Doppler velocimetry | Other | 1, 2 |
Primary outcome
Intraocular pressure
Time frame: 90 minutes
Retinal arterial and venous diameter
Time frame: 90 minutes
Retinal blood velocity
Time frame: 90 minutes
Pattern ERG
Time frame: measured once on the study day
2 secondary outcomes
Mean arterial pressure
Time frame: 90 minutes
Blood glucose
Time frame: measured once on the study day
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 20 Jul 2012.
- Derived from this study: PubMed 23307962Lasta M, Pemp B, Schmidl D, Boltz A, Kaya S, Palkovits S, Werkmeister R, Howorka K, Popa-Cherecheanu A, Garhofer G, Schmetterer L. Neurovascular dysfunction precedes neural dysfunction in the retina of patients with type 1 diabetes. Invest Ophthalmol Vis Sci. 2013 Jan 30;54(1):842-7. doi: 10.1167/iovs.12-10873.
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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 Gerhard Garhofer at 1 site in Austria.
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 5 inclusion and 6 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 20 Jul 2012. 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 Austria. 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?
Intraocular pressure (time frame: 90 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00712842, which also lists 1 linked publication.
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 20 Jul 2012.