Primary Open Angle GlaucomaNCT00626847
How Does Your Genetic Make-up (Profile) Influence Your Glaucoma?
An observational study of Primary Open Angle Glaucoma, run by Wills Eye at 1 site in United States.
Trial summary
Glaucoma is a group of diseases in which visual loss occurs because of damage to the optic nerve. Research has shown that certain genes may cause glaucoma in some cases. So far, research has only been able to find the genes responsible for glaucoma in a small percentage of people who have glaucoma. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2009
- Phase
- Observational
- 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
Study population: glaucoma clinic
Who may be able to join
- 40 yrs
- Caucasian or African American
- Male or female with POAG, PACG, PXFG,
- Normal
Who cannot join
- Other ophthamic co-morbidities
- Other ethnic groups
- Unable to understand and give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, 19107
About this study
Official title: Nuclear Genetic and Mitochondrial Influences in Glaucoma
Glaucoma is a group of diseases in which visual loss occurs because of damage to the optic nerve. Research has shown that certain genes may cause glaucoma in some cases. So far, research has only been able to find the genes responsible for glaucoma in a small percentage of people who have glaucoma. The purpose of this project is to study the genes in patients with and without glaucoma to find additional genes that may be responsible for causing glaucoma.
Read the detailed description
Four tubes of blood will be taken from 100 people. Of those, half will have primary open angle glaucoma (POAG) and the other half will be controls (normals), half will be caucasians and the other half will be african americans, half male and half female. All groups will have a routine ophthalmic eye exam, color vision, snellen vision, and visual field done.
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- primary open angle glaucoma, Nuclear Genetics, Mitochondrial DNA, POAG
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Primary Open Angle Glaucoma (POAG) | |
| 2 | Controls (Normals, patients without glaucoma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigators will quantify the spectrum of changes in mitochondrial respiration, relative mitochondrial DNA content, and oxidative stress associated with different types of glaucoma.
Measured: one blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Jefferson Medical College of Thomas Jefferson University, Thomas Jefferson University
- Responsible party
- Principal investigator, George L. Spaeth MD, Wills Eye
- Investigators
- George L Spaeth, MD, Principal investigator, Wills Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626847
- Sponsor's protocol ID
- IRB#07-826
- Status last verified
- Nov 2016
- First submitted
- 20 Feb 2008
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Two manuscripts have been written and published.
Publications
Abu-Amero KK, Azad TA, Spaeth GL, Myers J, Katz LJ, Moster M, Bosley TM. Unaltered myocilin expression in the blood of primary open angle glaucoma patients. Mol Vis. 2012;18:1004-9. Epub 2012 Apr 21.
PubMed 22550394Abu-Amero KK, Azad TA, Spaeth GL, Myers J, Katz LJ, Moster M, Bosley TM. Absence of altered expression of optineurin in primary open angle glaucoma patients. Mol Vis. 2012;18:1421-7. Epub 2012 Jun 1.
PubMed 22690120
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuclear Genetic and Mitochondrial Influences in Glaucoma
- ClinicalTrials.gov ID
- NCT00626847
- Acronym / sponsor ID
- IRB#07-826
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- primary open angle glaucoma, Nuclear Genetics, Mitochondrial DNA, POAG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Jefferson Medical College of Thomas Jefferson University, Thomas Jefferson University
- Study start
- Mar 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 29 Feb 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.
Glaucoma is a group of diseases in which visual loss occurs because of damage to the optic nerve. Research has shown that certain genes may cause glaucoma in some cases. So far, research has only been able to find the genes responsible for glaucoma in a small percentage of people who have glaucoma. The purpose of this project is to study the genes in patients with and without glaucoma to find additional genes that may be responsible for causing glaucoma.
Detailed description
Four tubes of blood will be taken from 100 people. Of those, half will have primary open angle glaucoma (POAG) and the other half will be controls (normals), half will be caucasians and the other half will be african americans, half male and half female. All groups will have a routine ophthalmic eye exam, color vision, snellen vision, and visual field done.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Primary Open Angle Glaucoma (POAG) |
| 2 | – | –Controls (Normals, patients without glaucoma) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- glaucoma clinic
Key inclusion criteria (4 listed)
- 40 yrs
- Caucasian or African American
- Male or female with POAG, PACG, PXFG,
- Normal
Key exclusion criteria (3 listed)
- Other ophthamic co-morbidities
- Other ethnic groups
- Unable to understand and give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The investigators will quantify the spectrum of changes in mitochondrial respiration, relative mitochondrial DNA content, and oxidative stress associated with different types of glaucoma.
Time frame: one blood draw
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 Nov 2016.
- Results publication: PubMed 22550394Abu-Amero KK, Azad TA, Spaeth GL, Myers J, Katz LJ, Moster M, Bosley TM. Unaltered myocilin expression in the blood of primary open angle glaucoma patients. Mol Vis. 2012;18:1004-9. Epub 2012 Apr 21.
- Results publication: PubMed 22690120Abu-Amero KK, Azad TA, Spaeth GL, Myers J, Katz LJ, Moster M, Bosley TM. Absence of altered expression of optineurin in primary open angle glaucoma patients. Mol Vis. 2012;18:1421-7. Epub 2012 Jun 1.
- Individual participant dataSharing planned: Yes. Two manuscripts have been written and published.
Related trials for Primary Open Angle Glaucoma
Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma
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.
George L Spaeth, MD principal investigator
Wills Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma, run by Wills Eye at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 21 Nov 2016. 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 United States. 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?
The investigators will quantify the spectrum of changes in mitochondrial respiration, relative mitochondrial DNA content, and oxidative stress associated with different types of glaucoma. (time frame: one blood draw). 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 NCT00626847, which also lists 2 linked publications.
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 Nov 2016.