Ophthalmologic Examinations After Infusion of ZK200775
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|ClinicalTrials.gov Identifier: NCT00999284|
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : October 21, 2009
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 or disease||Intervention/treatment||Phase|
|Visual Acuity||Drug: ZK200775 Drug: Sodium Chloride||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Ophthalmologic Examinations After 4-hour Infusion of ZK200775 in Healthy Elder Male Volunteers|
|Study Start Date :||December 1996|
|Actual Primary Completion Date :||April 1998|
|Actual Study Completion Date :||April 1998|
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.
- Visual acuity
- Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999284
|Charité Unviversitätsmedizin Berlin, Augenklinik Campus Virchow-Klinikum|
|Berlin, Germany, 13353|
|Study Director:||Thomas Staks, Dr.||Bayer|