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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
  Purpose

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 Intervention Phase
Visual Acuity
 Drug: ZK200775
Drug: Sodium Chloride
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ophthalmologic Examinations After 4-hour Infusion of ZK200775 in Healthy Elder Male Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Visual acuity

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

Enrollment: 18
Study Start Date: December 1996
Study Completion Date: April 1998
Primary Completion Date: April 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   55 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999284

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

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Thomas Staks, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00999284     History of Changes
Other Study ID Numbers: 96048
Study First Received: October 20, 2009
Last Updated: October 20, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 19, 2013