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Visual AcuityPhase 1NCT00999284

Ophthalmologic Examinations After Infusion of ZK200775

A Phase 1 study testing ZK200775 and Sodium Chloride in people with Visual Acuity, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Visual Acuity
What is being tested?
ZK200775 and Sodium Chloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteGermany
Study dates
Dec 1996to Apr 1998
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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
Show all 28Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité Unviversitätsmedizin Berlin, Augenklinik Campus Virchow-Klinikum

    Berlin, State of Berlin, 13353

Other trials in Germany

About this study

Official title: Ophthalmologic Examinations After 4-hour Infusion of ZK200775 in Healthy Elder Male Volunteers

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
Being tested
ZK200775, Sodium Chloride
Keywords
ZK200775 is tested for its effects on vision on healthy probands.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZK200775Drug

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

  • ZK200775Drug

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

  • Sodium ChlorideDrug

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

Study groups in NCT00999284
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSham infusion of sodium chloride 0.9%
Receives: Drug: Sodium Chloride
Low dose armActive comparatorInfusion of 0.3 mg/kg/h ZK200775 over 4 hours
Receives: Drug: ZK200775
High dose armActive comparatorInfusion of 0.75 mg/kg/h ZK200775 over 4 hours
Receives: Drug: ZK200775

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual acuity

Secondary outcomes (1)

  1. Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2009 (estimated)
  2. Study startDec 1996
  3. Primary completionApr 1998
  4. Study completionApr 1998

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00999284
Sponsor's protocol ID
96048
Status last verified
Oct 2009
First submitted
20 Oct 2009
Last updated
21 Oct 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Bergholz R, Staks T, Ruther K. Effects of the AMPA antagonist ZK 200775 on visual function: a randomized controlled trial. PLoS One. 2010 Aug 12;5(8):e12111. doi: 10.1371/journal.pone.0012111.

    PubMed 20711429

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZK200775 and Sodium Chloride in people with Visual Acuity, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual acuity. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00999284, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2009.

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Ophthalmologic Examinations After Infusion of ZK200775 | AzTrials