Ophthalmologic Examinations After Infusion of ZK200775
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).
|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|
- Visual acuity
- Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram
|Study Start Date:||December 1996|
|Study Completion Date:||April 1998|
|Primary Completion Date:||April 1998 (Final data collection date for primary outcome measure)|
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
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
Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.
|Charité Unviversitätsmedizin Berlin, Augenklinik Campus Virchow-Klinikum|
|Berlin, Germany, 13353|
|Study Director:||Thomas Staks, Dr.||Bayer|