- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00406731
Role of Endothelin- and Nitric Oxide-system in the Regulation of Optic Nerve Head Blood Flow During Changes in Ocular Perfusion Pressure
Role of endothelin-and Nitric Oxide-system in the Regulation of Optic Nerve Head Blood Flow During Changes in Ocular Perfusion Pressure
Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure. The existence of an effective autoregulation in the optic nerve circulation has been shown in animals and humans. The exact mechanism behind this autoregulation is still unknown. The motive for the investigation of optic nerve head (ONH) blood flow autoregulation is to enhance the understanding of pathologic eye conditions associated with ocular vascular disorders. To clarify the regulatory mechanisms of ONH microcirculation is of critical importance to understand the pathophysiology of glaucoma because there is evidence that glaucoma is associated with optic nerve head ischemia. Several studies indicate that a disturbed autoregulation might contribute to glaucomatous optic neuropathy. Previous findings suggest endothelial dysfunction in glaucomatous optic neuropathy, in particular alterations in endothelin- and nitric oxide- system, which both play an important role in local regulation of vascular tone.
In the present study, changes in ocular perfusion pressure will be performed during administration of drugs, which may potentially alter the pressure-flow relationship. These drugs include endothelin-1 and the nitric oxide synthase inhibitor NG-monomethyl-L-arginine (L-NMMA).
Study Overview
Status
Conditions
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1090
- Department of Clinical Pharmacology, Medical University of Vienna
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men aged between 18 and 35 years, nonsmokers
- Body mass index between 15th and 85th percentile (Must et al. 1991)
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 1 Dpt
Exclusion Criteria:
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
- History or presence of systemic or pulmonary hypertension, or other cardiac or pulmonary diseases
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
- Blood donation during the previous 3 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ONH pressure-flow relationship
Time Frame: up to 3 study days
|
up to 3 study days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gabriele Fuchsjaeger-Mayrl, MD,Univ.Doz., Department of Clinical Pharmacology, Medical University of Vienna
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPHT-080206
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ocular Physiology
-
Johnson & Johnson Vision Care, Inc.CompletedOcular PhysiologyUnited States
-
Johnson & Johnson Vision Care, Inc.CompletedOcular PhysiologyUnited States
-
Nidek Co. LTD.CompletedOcular PhysiologyUnited States
-
Medical University of ViennaCompletedOcular Physiology | MicrocirculationAustria
-
Johnson & Johnson Vision Care, Inc.CompletedOcular PhysiologyUnited States
-
Johnson & Johnson Vision Care, Inc.CompletedOcular PhysiologyUnited States
-
Medical University of ViennaWithdrawn
-
Medical University of ViennaWithdrawnIntraocular Pressure | Ocular PhysiologyAustria
-
Medical University of ViennaCompletedOcular Physiology | Regional Blood FlowAustria
-
Medical University of ViennaCompletedOcular Physiology | Regional Blood FlowAustria
Clinical Trials on NG-monomethyl-L-arginine (L-NMMA)
-
Medical University of ViennaTerminatedOcular Physiology | Regional Blood FlowAustria
-
Regional Hospital HolstebroCompleted
-
Regional Hospital HolstebroAarhus University HospitalUnknownEssential HypertensionDenmark
-
The Methodist Hospital Research InstituteActive, not recruitingNon-Small Cell Lung Cancer | DNA Repair-Deficiency Disorders | Head and Neck Squamous Cell Carcinoma | Urothelial Carcinoma Bladder | Classical Hodgkin Lymphoma | Malignant MelanomaUnited States
-
Regional Hospital HolstebroCompletedHealthy | Obstructive Sleep ApneaDenmark
-
Brigham and Women's HospitalCompleted
-
Mayo ClinicAmerican Diabetes AssociationCompleted
-
University of AarhusCompletedDiabetic Maculopathy | Diabetes Mellitus Type 1Denmark
-
Uppsala UniversityThe Swedish Society of Medicine; Bengt Ihre FoundationCompletedGastrointestinal Motility Disorder | Disturbance of Salivary SecretionSweden
-
Regional Hospital HolstebroCompleted