Ophthalmologic Examinations After Infusion of ZK200775

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00999284
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : October 21, 2009
Information provided by:
Charite University, Berlin, Germany

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Visual Acuity Drug: ZK200775 Drug: Sodium Chloride Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ophthalmologic Examinations After 4-hour Infusion of ZK200775 in Healthy Elder Male Volunteers
Study Start Date : December 1996
Actual Primary Completion Date : April 1998
Actual Study Completion Date : April 1998

Arm Intervention/treatment
Placebo Comparator: Placebo
Sham infusion of sodium chloride 0.9%
Drug: Sodium Chloride
Intravenous infusion of sodium chloride over a period of 4 hours.
Active Comparator: Low dose arm
Infusion of 0.3 mg/kg/h ZK200775 over 4 hours
Drug: ZK200775
Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.
Active Comparator: High dose arm
Infusion of 0.75 mg/kg/h ZK200775 over 4 hours
Drug: ZK200775
Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.

Primary Outcome Measures :
  1. Visual acuity

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

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Ages Eligible for Study:   55 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00999284

Charité Unviversitätsmedizin Berlin, Augenklinik Campus Virchow-Klinikum
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Study Director: Thomas Staks, Dr. Bayer

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Thomas Staks, Bayer Schering Pharma AG Identifier: NCT00999284     History of Changes
Other Study ID Numbers: 96048
First Posted: October 21, 2009    Key Record Dates
Last Update Posted: October 21, 2009
Last Verified: October 2009

Keywords provided by Charite University, Berlin, Germany:
ZK200775 is tested for its effects on vision on healthy probands.