Ophthalmologic Examinations After Infusion of ZK200775

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00999284
First received: October 20, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 20, 2009
October 20, 2009
December 1996
April 1998   (final data collection date for primary outcome measure)
Visual acuity
Same as current
No Changes Posted
Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram
Same as current
Not Provided
Not Provided
 
Ophthalmologic Examinations After Infusion of ZK200775
Ophthalmologic Examinations After 4-hour Infusion of ZK200775 in Healthy Elder Male Volunteers

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Visual Acuity
  • Drug: ZK200775
    Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.
  • Drug: ZK200775
    Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.
  • Drug: Sodium Chloride
    Intravenous infusion of sodium chloride over a period of 4 hours.
  • Placebo Comparator: Placebo
    Sham infusion of sodium chloride 0.9%
    Intervention: Drug: Sodium Chloride
  • Active Comparator: Low dose arm
    Infusion of 0.3 mg/kg/h ZK200775 over 4 hours
    Intervention: Drug: ZK200775
  • Active Comparator: High dose arm
    Infusion of 0.75 mg/kg/h ZK200775 over 4 hours
    Intervention: Drug: ZK200775
Bergholz R, Staks T, Rüther K. Effects of the AMPA antagonist ZK 200775 on visual function: a randomized controlled trial. PLoS One. 2010 Aug 12;5(8):e12111.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
April 1998
April 1998   (final data collection date for primary outcome measure)

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
Male
55 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00999284
96048
Yes
Dr. Thomas Staks, Bayer Schering Pharma AG
Charite University, Berlin, Germany
Bayer
Study Director: Thomas Staks, Dr. Bayer
Charite University, Berlin, Germany
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP