Effects of Indomethacin on Retinal and Choroidal Blood Flow in Healthy Volunteers
Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ocular Physiology; Regional Blood Flow
Intervention: indometacine (drug) effect on ocular blood flow (Drug)
Phase: N/A
Status: Completed
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s):
Gabriele Fuchsjaeger-Mayrl, MD, Principal Investigator, Affiliation: Department of Clinical Pharmacology, Medical University of Vienna
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.
Clinical Details
Official title: Effects of Indomethacin on Retinal and Choroidal Blood Flow in Healthy Volunteers
Study design: Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Retinal and choroidal blood flow
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Male.
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
Locations and Contacts
Department of Clinical Pharmacology, Vienna 1090, Austria
Additional Information
Starting date: January 2006
Ending date: August 2006
Last updated: February 9, 2007
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