ChoroideremiaPhase 1/2NCT01654562
The Short-term Effects of Simvastatin on the Vision of Males Affected by Choroideremia
A Phase 1/2 study testing Simvastatin in people with Choroideremia, run by University of Alberta at 1 site in Canada.
Trial summary
Primary objective: To examine the short-term effects of of simvastatin on the vision on males with choroideremia, evaluated by full-field scotopic threshold testing. The investigators hypothesize that they will see a reversible decrease in the dark-adapted vision in participants taking simvastatin. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Choroideremia
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Jul 2013
- Phase
- Phase 1/2
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- Male
- Diagnosed with choroideremia and in good health
- Willing to allow his general practitioner and consultant, if appropriate, to be notified of participation in the study
- Over age of 18 years
Who cannot join
- Female
- Significant health disease, disorder, or medication, which, in the opinion of the investigator, would put the patient at risk if he were to take simvastatin
- Already taking simvastatin or another statin
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ophthalmology Research Office, University of Alberta
Edmonton, Alberta, T6G 2R3
About this study
Official title: A Repeated Measures Study of Simvastatin on Choroideremia: Simvastatin Intervention and Reversal in Choroideremia Patients and Age-matched Controls.
Primary objective: To examine the short-term effects of of simvastatin on the vision on males with choroideremia, evaluated by full-field scotopic threshold testing. The investigators hypothesize that they will see a reversible decrease in the dark-adapted vision in participants taking simvastatin.
- Conditions
- Choroideremia
- Being tested
- Simvastatin
- Medical subject headings
- Choroideremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Zocor
Simvastatin 40mg daily by mouth for 5 weeks (4-6 week window) followed by 5 week washout period (4-6 week window).
| Study group | Role | What they receive |
|---|---|---|
| CHM | Experimental | Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period. Receives: Drug: Simvastatin |
| Age-matched controls | Active comparator | Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period. Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full-field scotopic threshold
Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.
Measured: 5 weeks (4-6 weeks)
Secondary outcomes (3)
Microperimetry, OCT, fundus autofluorescence, ERG, VA
Correlation of retinal structure and function with changes in FST after administration of simvastatin.
Measured: 5 weeks (4-6 weeks)
Microperimetry, OCT, fundus autofluorescence, ERG, VA
Correlation of retinal structure and function with changes in FST after washout of simvastatin.
Measured: 5 weeks (4-6 weeks)
Full-field scotopic threshold
Full-field scotopic threshold after washout of simvastatin.
Measured: 5 weeks (4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: The study has been terminated due to limited participant enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChoroideremiaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian M MacDonald, MD, CM, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654562
- Sponsor's protocol ID
- CHM-STATIN
- Status last verified
- Sep 2013
- First submitted
- 27 Jul 2012
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Repeated Measures Study of Simvastatin on Choroideremia: Simvastatin Intervention and Reversal in Choroideremia Patients and Age-matched Controls.
- ClinicalTrials.gov ID
- NCT01654562
- Acronym / sponsor ID
- CHM-STATIN
- Conditions
- Choroideremia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been terminated due to limited participant enrollment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 31 Jul 2012 (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.
Primary objective: To examine the short-term effects of of simvastatin on the vision on males with choroideremia, evaluated by full-field scotopic threshold testing. The investigators hypothesize that they will see a reversible decrease in the dark-adapted vision in participants taking simvastatin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHM | Experimental | Drug: SimvastatinAdministration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period. |
| Age-matched controls | Active comparator | Drug: SimvastatinAdministration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the study
- Male
- Diagnosed with choroideremia and in good health
- Willing to allow his general practitioner and consultant, if appropriate, to be notified of participation in the study
- Over age of 18 years
Key exclusion criteria (3 listed)
- Female
- Significant health disease, disorder, or medication, which, in the opinion of the investigator, would put the patient at risk if he were to take simvastatin
- Already taking simvastatin or another statin
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 |
|---|---|---|
| SimvastatinAlso: ZocorSimvastatin 40mg daily by mouth for 5 weeks (4-6 week window) followed by 5 week washout period (4-6 week window). | Drug | Age-matched controls, CHM |
Primary outcome
Full-field scotopic threshold
Time frame: 5 weeks (4-6 weeks)
Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.
3 secondary outcomes
Microperimetry, OCT, fundus autofluorescence, ERG, VA
Time frame: 5 weeks (4-6 weeks)
Microperimetry, OCT, fundus autofluorescence, ERG, VA
Time frame: 5 weeks (4-6 weeks)
Full-field scotopic threshold
Time frame: 5 weeks (4-6 weeks)
Results and safety
The study was stopped early (reason given: The study has been terminated due to limited participant enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
Related trials for Choroideremia
RecruitingObservational study
Inherited Retinal Degenerative Disease Registry
Eye Diseases Hereditary, Retinal Disease
RecruitingObservational study
High Resolution Retinal Imaging
Stargardts, Retinitis Pigmentosa
Active, not recruitingPhase 1
Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa or Choroideremia Patients (ENVISION)
Retinitis Pigmentosa, Choroideremia
Recruiting
HYPER MIND - Hyperoxia Effects on Cerebral Hemodynamics
Hyperoxemia, Cerebrovascular Circulation
Active, not recruitingPhase 1
Dose Escalation Study of Intravitreal 4D-110 in Patients With Choroideremia
Choroideremia
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.
Ian M MacDonald, MD, CM principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Simvastatin in people with Choroideremia, run by University of Alberta at 1 site in Canada.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Oct 2014. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: The study has been terminated due to limited participant enrollment.). Results are not available in the source record.
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?
Full-field scotopic threshold (time frame: 5 weeks (4-6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2014.