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Completed

NCT Number: NCT00999284

Ophthalmologic Examinations After Infusion of ZK200775

ZK 200775 is an antagonist at the α-Amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA) receptor and had earned attention a possible neuroprotective agent in cerebral ischemia. Probands receiving the agent within a stroke therapy related Phase I trial reported on an alteration of visual perception. In this trial, the effects of ZK 200775 on the visual system will be analyzed in detail.

In a randomised, placebo-controlled, double-blind study eyes and vision will be examined before and after the intravenous administration of ZK 200775. The following methods will be applied: clinical examination, visual acuity, ophthalmoscopy, colour vision, rod absolute threshold, central visual field, pattern-reversal visual evoked potentials (pVEP), ON-OFF and full-field electroretinogram (ERG).

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Key information

Conditions

Visual Acuity

Age range

55 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Charité Unviversitätsmedizin Berlin, Augenklinik Campus Virchow-Klinikum

Berlin, State of Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The participant must be a voluntary proband
  • Age between 55 and 65 years
  • Body weight must not exceed the following value: Body height in cm minus 100 = body weight [kg] +/- 20%
  • Male sex
  • Written informed consent
  • Physical examination: Probands must show normal findings without clinical relevance, mental and physical health is required;

Exclusion criteria

  • Clinical history:
  • Substantial pre-existing medical condition
  • Known allergy to the employed effective components or galenic components
  • Medicaments and drugs
  • Intake of systemically or locally acting drugs which conflict with the aim of the trial or that can influence the results (antipsychotic drugs, antidepressants, barbiturates and benzodiazepines)
  • A clinical history that hints to substance or alcohol abuse
  • Nicotine abuse of more than 10 cigarettes a day
  • Consumption of alcoholic beverages on the day prior to the examinations
  • Extreme physical stress (sports or work) within 8 days prior to the examinations
  • Blood donation within 2 months prior to the examinations
  • Relevant vaccination or stay abroad
  • Special or onesided alimentation (strict vegetarianism, low-caloric diet)
  • Simultaneous participation in another clinical trial
  • Vital signs (after 3 minutes of rest)
  • Blood pressure with systolic values > 160 mmHg and / or diastolic values > 95 mmHg
  • Heart frequency: Values beyond 50-100 beats per minute
  • Electrocardiogram
  • abnormal 12-channel ECG
  • Laboratory findings
  • Hepatitis antigen (HBsAG), hepatitis C-antibodies or positive HIV-test
  • Clinical pharmacology
  • positive drug test
  • clinically relevant abnormalities of the examined parameters
  • Opinion of the investigator: when due to scientific or personal reasons or matters of compliance or safety a patient should not take part in the trial
  • Opacification of optic media, retinal disease, optic nerve disease, amblyopia or color vision defects
  • Status post intraocular surgery (exception: cataract surgery with implantation of a posterior chamber lens), laser coagulation
  • Myopia > -5 diopters, hyperopia > +5 diopters
  • Narrow angle glaucoma

Treatment and study plan

ZK200775

Drug

Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.

Sodium Chloride

Drug

Intravenous infusion of sodium chloride over a period of 4 hours.

Primary outcomes

  1. Visual acuity

Secondary outcomes

  1. Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Bayer

Registry information

Official study title

Ophthalmologic Examinations After 4-hour Infusion of ZK200775 in Healthy Elder Male Volunteers

Important dates

Study start
1996
Primary completion
1998
Study completion
1998
First posted
Oct 21, 2009
Registry last updated
Oct 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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