Visual Acuity
Conditions
Keywords
ZK200775 is tested for its effects on vision on healthy probands.
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).
Interventions
DRUGZK200775
Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.
DRUGSodium Chloride
Intravenous infusion of sodium chloride over a period of 4 hours.
Sponsors
Bayer
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
55 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity | — |
Secondary
| Measure | Time frame |
|---|---|
| Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram | — |
Countries
Germany
Outcome results
None listed