Ophthalmologic Examinations After Infusion of ZK200775

NCT ID: NCT00999284

Last Updated: 2009-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-12-31
• Study Completion Date: 1998-04-30

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).

Conditions

Visual Acuity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Sham infusion of sodium chloride 0.9%

Group Type: PLACEBO_COMPARATOR

Sodium Chloride

Intervention Type: DRUG

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

Low dose arm

Infusion of 0.3 mg/kg/h ZK200775 over 4 hours

Group Type: ACTIVE_COMPARATOR

ZK200775

Intervention Type: DRUG

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

High dose arm

Infusion of 0.75 mg/kg/h ZK200775 over 4 hours

Group Type: ACTIVE_COMPARATOR

ZK200775

Intervention Type: DRUG

Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.

Interventions

ZK200775

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

Intervention Type: DRUG

ZK200775

Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.

Intervention Type: DRUG

Sodium Chloride

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Bayer Schering Pharma AG

Principal Investigators

Thomas Staks, Dr.

Role: STUDY_DIRECTOR

Bayer

Locations

Charité Unviversitätsmedizin Berlin, Augenklinik Campus Virchow-Klinikum

Berlin, State of Berlin, Germany

Countries

Germany

References

Bergholz R, Staks T, Ruther K. Effects of the AMPA antagonist ZK 200775 on visual function: a randomized controlled trial. PLoS One. 2010 Aug 12;5(8):e12111. doi: 10.1371/journal.pone.0012111.

Reference Type: DERIVED

PMID: 20711429 (View on PubMed)

Other Identifiers

96048

Identifier Type: -

Identifier Source: org_study_id