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Ophthalmologic Examinations After Infusion of ZK200775

NCT00999284 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2009-10-21

No results posted yet for this study

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).

Conditions

  • Visual Acuity

Interventions

DRUG

ZK200775

Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.

DRUG

Sodium Chloride

Intravenous infusion of sodium chloride over a period of 4 hours.

DRUG

ZK200775

Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Thomas Staks, Dr. · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1996-12-31
Primary Completion
1998-04-30
Completion
1998-04-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00999284 on ClinicalTrials.gov