Ophthalmologic Examinations After Infusion of ZK200775

Visual Acuity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999284
• Other study ID #: 96048
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2009
• Last updated: October 20, 2009
• Start date: December 1996
• Est. completion date: April 1998

Study information

• Verified date: October 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 1998
• Est. primary completion date: April 1998
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Drug:
• ZK200775
Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.
• ZK200775
Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.
• Sodium Chloride
Intravenous infusion of sodium chloride over a period of 4 hours.

Locations

Country	Name	City	State
Germany	Charité Unviversitätsmedizin Berlin, Augenklinik Campus Virchow-Klinikum	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity
Secondary	Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram