Status:

COMPLETED

Effect of Retaron® on Oxygen Induced Retinal Vasoconstriction in LPS Induced Inflammatory Model in Humans

Lead Sponsor:

Medical University of Vienna

Conditions:

Imparied Retinal Vascular Reactivity

Healthy Subjects

Eligibility:

MALE

18-35 years

Phase:

NA

Brief Summary

Oxidative stress has been implicated to play a pathogenic role in many disease processes, especially in age-related disorders such as age-related macular degeneration. It has been hypothesized that an...

Eligibility Criteria

Inclusion

  • 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 \< 3 Dpt.

Exclusion

  • 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, vitamins and minerals supplements as well
  • 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 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

Key Trial Info

Start Date :

January 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2014

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT02221089

Start Date

January 1 2013

End Date

July 1 2014

Last Update

August 20 2014

Active Locations (1)

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1

Department of clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, Austria, 1080