Ophthalmologic Examinations After Infusion of ZK200775
- Registration Number
- NCT00999284
- Lead Sponsor
- Charite University, Berlin, Germany
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
- 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;
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Clinical history:
- Substantial pre-existing medical condition
- Known allergy to the employed effective components or galenic components
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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
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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
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Electrocardiogram
- abnormal 12-channel ECG
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Laboratory findings
- Hepatitis antigen (HBsAG), hepatitis C-antibodies or positive HIV-test
-
Clinical pharmacology
- positive drug test
- clinically relevant abnormalities of the examined parameters
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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
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Opacification of optic media, retinal disease, optic nerve disease, amblyopia or color vision defects
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Status post intraocular surgery (exception: cataract surgery with implantation of a posterior chamber lens), laser coagulation
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Myopia > -5 diopters, hyperopia > +5 diopters
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Narrow angle glaucoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Sodium Chloride Sham infusion of sodium chloride 0.9% Low dose arm ZK200775 Infusion of 0.3 mg/kg/h ZK200775 over 4 hours High dose arm ZK200775 Infusion of 0.75 mg/kg/h ZK200775 over 4 hours
- Primary Outcome Measures
Name Time Method Visual acuity
- Secondary Outcome Measures
Name Time Method Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram
Trial Locations
- Locations (1)
Charité Unviversitätsmedizin Berlin, Augenklinik Campus Virchow-Klinikum
🇩🇪Berlin, Germany