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Effects of Indomethacin on Retinal and Choroidal Blood Flow in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00275730
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : February 12, 2007
Sponsor:
Information provided by:
Medical University of Vienna

Study Description
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Brief Summary:

Prostaglandins (PG) are known to alter regional ocular blood flow and exhibit vasoactive properties in isolated ocular blood vessels. A variety of animal experiments indicate that endogenous PGs play a role in the regulation of retinal (RBF) and choroidal (ChBF) blood flow. There is also evidence that the prostaglandin pathway is involved in the activation of NO production in humans, however, the mechanisms for interactions between PG and NO in ocular vasculature are still unclear.

Animal studies suggest that retinal and choroidal blood flow decrease after administration of indomethacin (a nonspecific cyclooxygenase inhibitor). More recently, it has been shown that indomethacin injected intravenously decreased optic nerve oxygen tension and reduced the CO2 reactivity. This is probably the result of decreased blood flow through vasoconstriction of vessels in the optic nerve. Systemic administration of indomethacin also diminishes cerebral, renal and mesenteric blood flow by an unknown mechanism. However, no clinical trials exist so far investigating the effects of indomethacin on ocular blood flow. Therefore, the aim of this study is to investigate the effect of indomethacin on ocular blood flow in healthy humans.


Condition or disease Intervention/treatment Phase
Ocular Physiology Regional Blood Flow Drug: indometacine (drug) effect on ocular blood flow Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: Effects of Indomethacin on Retinal and Choroidal Blood Flow in Healthy Volunteers
Study Start Date : January 2006
Study Completion Date : August 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Retinal and choroidal blood flow

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men aged between 18 and 35 years, nonsmokers
  • Body mass index between 15th and 85th percentile
  • 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 < 3 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 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
  • Ametropy less than 3 dpt
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275730


Locations
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Austria
Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Gabriele Fuchsjaeger-Mayrl, MD Department of Clinical Pharmacology, Medical University of Vienna
More Information
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ClinicalTrials.gov Identifier: NCT00275730    
Other Study ID Numbers: 9-11-2004
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: February 12, 2007
Last Verified: February 2007
Keywords provided by Medical University of Vienna:
indometacine
retinal blood flow
choroidal blood flow
Additional relevant MeSH terms:
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Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
 Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action