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.
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
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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sham infusion of sodium chloride 0.9% Receives: Drug: Sodium Chloride |
| Low dose arm | Active comparator | Infusion of 0.3 mg/kg/h ZK200775 over 4 hours Receives: Drug: ZK200775 |
| High dose arm | Active comparator | Infusion 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.
Visual acuity
Secondary outcomes (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.
- First posted21 Oct 2009 (estimated)
- Study startDec 1996
- Primary completionApr 1998
- Study completionApr 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Thomas Staks, Dr., Study director, Bayer
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ophthalmologic Examinations After 4-hour Infusion of ZK200775 in Healthy Elder Male Volunteers
- ClinicalTrials.gov ID
- NCT00999284
- Acronym / sponsor ID
- 96048
- Conditions
- Visual Acuity
- Keywords
- ZK200775 is tested for its effects on vision on healthy probands.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Dec 1996
- Primary completion
- Apr 1998 (actual)
- Study completion
- Apr 1998 (actual)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Sodium ChlorideSham infusion of sodium chloride 0.9% |
| Low dose arm | Active comparator | Drug: ZK200775Infusion of 0.3 mg/kg/h ZK200775 over 4 hours |
| High dose arm | Active comparator | Drug: ZK200775Infusion of 0.75 mg/kg/h ZK200775 over 4 hours |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (28 listed)
- Clinical history:
- Medicaments and drugs
- Vital signs (after 3 minutes of rest)
- Electrocardiogram
- Laboratory findings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZK200775Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours. | Drug | Low dose arm |
| ZK200775Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours. | Drug | High dose arm |
| Sodium ChlorideIntravenous infusion of sodium chloride over a period of 4 hours. | Drug | Placebo |
Primary outcome
Visual acuity
1 secondary outcome
Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2009.
- Derived from this study: PubMed 20711429Bergholz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Staks, Dr. study director
Bayer
1 site in 1 country: see every site and its status.
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.