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

Regional Blood Flow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275730
• Other study ID #: 9-11-2004
• Status: Completed
• Phase: N/A
• First received: January 11, 2006
• Last updated: February 9, 2007
• Start date: January 2006
• Est. completion date: August 2006

Study information

• Verified date: February 2007
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria:Bundesministerium für Gesundheit und Frauen
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Ocular Physiology
• Regional Blood Flow

Intervention

Drug:
• indometacine (drug) effect on ocular blood flow

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal and choroidal blood flow