GlaucomaNCT00629044
Genetic Polymorphysm of Cholesterol 24 S Hydroxylase in Patients With Glaucoma and AMD
A study testing Assessing the blood level of cholesterol 24 S Hydroxylase in people with Glaucoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim of this study is to assess the implicitement of the cholesterol 24 S hydroxylase gene and the 24 S hydroxycholesterol in glaucoma and in age related macular degeneration. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Assessing the blood level of cholesterol 24 S Hydroxylase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2007to Jan 2011
- Phase
- Interventional
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with Glaucoma
- Patient with AMD
- Healthy patient
Who cannot join
- All patients who use any treatment in order to maintain in normal value their blood cholesterol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude du Polymorphysme génétique de la cholestérol 24S Hydroxylase et Des Teneurs en 24S hydroxycholestérol Chez Des Patients Atteints de Glaucome ou de dégénérescence Maculaire liée à l'âge.
The aim of this study is to assess the implicitement of the cholesterol 24 S hydroxylase gene and the 24 S hydroxycholesterol in glaucoma and in age related macular degeneration.
- Conditions
- Glaucoma
- Being tested
- Assessing the blood level of cholesterol 24 S Hydroxylase
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessing the blood level of cholesterol 24 S HydroxylaseBiological
Comparison of venous blood level of Cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with Glaucoma and AMD and in healthy subjects.
Assessing the blood level of cholesterol 24 S hydroxylaseBiological
Comparison of venous blood level of cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with Glaucoma, AMD end in healthy subjects
assessing the blood level of cholesterol 24 S hydroxylaseBiological
Comparison of venous blood level of cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with glaucoma, AMD and in healthy subjects
| Study group | Role | What they receive |
|---|---|---|
| G | Active comparator | Not described Receives: Biological: Assessing the blood level of cholesterol 24 S Hydroxylase |
| AMD | Active comparator | Not described Receives: Biological: Assessing the blood level of cholesterol 24 S hydroxylase |
| Healthy subjects | Active comparator | Not described Receives: Biological: assessing the blood level of cholesterol 24 S hydroxylase |
What is being measured
The primary outcome is the main question the study is designed to answer.
To know if cholesterol 24 S hydroxylase and 24 hydroxycholesterol are involve in Glaucoma and AMD
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionNov 2009
- Study completionJan 2011
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 GlaucomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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 N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Investigators
- Catherine Creuzot-Gracher, MD, PhD, Principal investigator, CHU Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629044
- Sponsor's protocol ID
- PHRC IR 2006
- Status last verified
- Aug 2009
- First submitted
- 25 Feb 2008
- Last updated
- 28 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Joffre C, Souchier M, Gregoire S, Viau S, Bretillon L, Acar N, Bron AM, Creuzot-Garcher C. Differences in meibomian fatty acid composition in patients with meibomian gland dysfunction and aqueous-deficient dry eye. Br J Ophthalmol. 2008 Jan;92(1):116-9. doi: 10.1136/bjo.2007.126144.
PubMed 18156378
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude du Polymorphysme génétique de la cholestérol 24S Hydroxylase et Des Teneurs en 24S hydroxycholestérol Chez Des Patients Atteints de Glaucome ou de dégénérescence Maculaire liée à l'âge.
- ClinicalTrials.gov ID
- NCT00629044
- Acronym / sponsor ID
- PHRC IR 2006
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 5 Mar 2008 (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.
The aim of this study is to assess the implicitement of the cholesterol 24 S hydroxylase gene and the 24 S hydroxycholesterol in glaucoma and in age related macular degeneration.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G | Active comparator | Biological: Assessing the blood level of cholesterol 24 S Hydroxylase |
| AMD | Active comparator | Biological: Assessing the blood level of cholesterol 24 S hydroxylase |
| Healthy subjects | Active comparator | Biological: assessing the blood level of cholesterol 24 S hydroxylase |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with Glaucoma
- Patient with AMD
- Healthy patient
Key exclusion criteria (1 listed)
- All patients who use any treatment in order to maintain in normal value their blood cholesterol
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 |
|---|---|---|
| Assessing the blood level of cholesterol 24 S HydroxylaseComparison of venous blood level of Cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with Glaucoma and AMD and in healthy subjects. | Biological | G |
| Assessing the blood level of cholesterol 24 S hydroxylaseComparison of venous blood level of cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with Glaucoma, AMD end in healthy subjects | Biological | AMD |
| assessing the blood level of cholesterol 24 S hydroxylaseComparison of venous blood level of cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with glaucoma, AMD and in healthy subjects | Biological | Healthy subjects |
Primary outcome
To know if cholesterol 24 S hydroxylase and 24 hydroxycholesterol are involve in Glaucoma and AMD
Time frame: 2 years
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 28 Mar 2011.
- Background: PubMed 18156378Joffre C, Souchier M, Gregoire S, Viau S, Bretillon L, Acar N, Bron AM, Creuzot-Garcher C. Differences in meibomian fatty acid composition in patients with meibomian gland dysfunction and aqueous-deficient dry eye. Br J Ophthalmol. 2008 Jan;92(1):116-9. doi: 10.1136/bjo.2007.126144.
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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.
Catherine Creuzot-Gracher, MD, PhD principal investigator
CHU Dijon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessing the blood level of cholesterol 24 S Hydroxylase in people with Glaucoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 3 inclusion and 1 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 28 Mar 2011. 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 France. 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.
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?
To know if cholesterol 24 S hydroxylase and 24 hydroxycholesterol are involve in Glaucoma and AMD (time frame: 2 years). 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 NCT00629044, 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 28 Mar 2011.