Primary Open Angle GlaucomaSTARFISHNCT01442896
STudy to Assess Rapid Disease Progression by Clinical and Genetic Factors In Glaucoma patientS That Are High Risk
An observational study of Primary Open Angle Glaucoma, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to perform exploratory analyses to evaluate rates of functional and structural change in glaucoma, to identify predictors of rapid progression in patients with glaucoma and to identify possible genetic factors and biomarkers associated with the disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2011to 18 Dec 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary Open Angle Glaucoma Health Individuals
Who may be able to join
- Subjects will be eligible if the following criteria are met:
- Group A (diagnosis of primary open-angle glaucoma or pseudo-exfoliative glaucoma) - subjects with documented disease progression in the past 3 years and high IOP (IOP above target), disc hemorrhage (within 3 years), family history of glaucoma-related vision loss or thin central cornea (<510um),
- Progression is confirmed with repeatable abnormal standard automated perimetry (SAP) or progressive glaucomatous optic neuropathy
- For patients that have had previous glaucoma surgery, they can be included if they have had documented glaucomatous progression post-surgery
- Best corrected visual acuity of 20/40 or better at enrollment
- Group B (healthy controls)- healthy subjects without any ophthalmic disease and an IOP < 22mmHg
- o Normal appearing optic disc and no evidence of optic disc damage
- Ability to provide written informed consent for participation in this study
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Subjects with an ocular disease other than glaucoma
- Subjects participating in a long-term interventional clinical trial
- Subjects with any other medical condition which would prohibit them from making all study visits within the 24 months
- Glaucoma patients who have not demonstrated disease progression in the past 3 years
- Patients with diagnosis of pigmentary dispersion syndrome/glaucoma
Show all 16Show fewer
- Patients that have had glaucoma surgery and have IOP ≤ 12 mm Hg
- Patients with advanced glaucoma with MD ≤ -20 dB
- Patients with a history of LASIK surgery
- Patients with myopia > -6.0 diopters.
- Patients with hyperopia >+6.0 diopters.
- In the investigator's opinion, any patient that cannot satisfactorily complete all of the structural and functional testing included in the protocol (investigator determined)
- Unable to perform reliable VF testing (Fixation losses 33% or less, false negative rate 33% or less and false positive rate of 15% or less) at the time of study entry
- In the investigator's opinion, any patient with an ocular disease that could impact study assessments
- Patients with cataracts in which surgery is planned or anticipated within the next 3 months.
- Patients with narrow angles in which laser iridotomy is planned or anticipated within the next 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hamilton Glaucoma Center, UCSD
La Jolla, California, 92093
About this study
Official title: STudy to Assess Rapid Disease Progression by Clinical and Genetic Factors In Glaucoma patientS That Are High Risk (STARFISH)
The purpose of this study is to perform exploratory analyses to evaluate rates of functional and structural change in glaucoma, to identify predictors of rapid progression in patients with glaucoma and to identify possible genetic factors and biomarkers associated with the disease.
Read the detailed description
PRIMARY OBJECTIVES
To identify and combine a set of predictors (i.e. by statistical modeling, machine learning classifiers or neural networks) to predict progression in glaucoma patients To determine how to most sensitively and specifically determine progression for a trial of a potential neuroprotective agent.
SECONDARY OBJECTIVES
To evaluate genetic and other potential biomarkers associated with progression in glaucoma.
To evaluate tests currently used on glaucoma patients to better predict which ones are most sensitive to detect disease progression and measure rates of change.
To assess progression by structural and functional tests:
- Optic disc stereophotographs
- Cirrus OCT
- RTVue OCT
- Standard Automated Perimetry (SAP)
- Frequency Doubling Technology Matrix
- Conditions
- Primary Open Angle Glaucoma
- 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 |
|---|---|---|
| Primary Open Angle Glaucoma | • Group A (diagnosis of primary open-angle glaucoma or pseudo-exfoliative glaucoma) - subjects with documented disease progression in the past and high IOP (IOP above target), disc hemorrhage, family history of glaucoma-related vision loss or thin central cornea (<510um), * Progression is confirmed with repeatable abnormal standard automated perimetry (SAP) or progressive glaucomatous optic neuropathy * For patients that have had previous glaucoma surgery, they can be included if they have had documented glaucomatous progression post-surgery * Best corrected visual acuity of 20/40 or better at enrollment | |
| Healthy Individuals | • Group B (healthy controls)- healthy subjects without any ophthalmic disease and an IOP < 22mmHg o Normal appearing optic disc and no evidence of optic disc damage |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study start1 Sep 2011
- Primary completion18 Dec 2015
- Study completion18 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Robert Weinreb, University of California, San Diego
- Investigators
- Robert Weinreb, MD, Principal investigator, UCSD Shiley Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442896
- Sponsor's protocol ID
- 111223
- Acronym
- STARFISH
- Status last verified
- Jan 2024
- First submitted
- 26 Sep 2011
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Medeiros FA, Alencar LM, Zangwill LM, Sample PA, Weinreb RN. The Relationship between intraocular pressure and progressive retinal nerve fiber layer loss in glaucoma. Ophthalmology. 2009 Jun;116(6):1125-33.e1-3. doi: 10.1016/j.ophtha.2008.12.062. Epub 2009 Apr 19.
PubMed 19376584Medeiros FA, Alencar LM, Sample PA, Zangwill LM, Susanna R Jr, Weinreb RN. The relationship between intraocular pressure reduction and rates of progressive visual field loss in eyes with optic disc hemorrhage. Ophthalmology. 2010 Nov;117(11):2061-6. doi: 10.1016/j.ophtha.2010.02.015. Epub 2010 Jun 11.
PubMed 20541265Medeiros FA, Zangwill LM, Alencar LM, Bowd C, Sample PA, Susanna R Jr, Weinreb RN. Detection of glaucoma progression with stratus OCT retinal nerve fiber layer, optic nerve head, and macular thickness measurements. Invest Ophthalmol Vis Sci. 2009 Dec;50(12):5741-8. doi: 10.1167/iovs.09-3715. Epub 2009 Oct 8.
PubMed 19815731Alencar LM, Zangwill LM, Weinreb RN, Bowd C, Vizzeri G, Sample PA, Susanna R Jr, Medeiros FA. Agreement for detecting glaucoma progression with the GDx guided progression analysis, automated perimetry, and optic disc photography. Ophthalmology. 2010 Mar;117(3):462-70. doi: 10.1016/j.ophtha.2009.08.012. Epub 2009 Dec 24.
PubMed 20036010
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STudy to Assess Rapid Disease Progression by Clinical and Genetic Factors In Glaucoma patientS That Are High Risk (STARFISH)
- ClinicalTrials.gov ID
- NCT01442896
- Acronym / sponsor ID
- STARFISH / 111223
- Conditions
- Primary Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 18 Dec 2015 (actual)
- Study completion
- 18 Dec 2015 (actual)
- First posted
- 29 Sep 2011 (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 purpose of this study is to perform exploratory analyses to evaluate rates of functional and structural change in glaucoma, to identify predictors of rapid progression in patients with glaucoma and to identify possible genetic factors and biomarkers associated with the disease.
Detailed description
PRIMARY OBJECTIVES
To identify and combine a set of predictors (i.e. by statistical modeling, machine learning classifiers or neural networks) to predict progression in glaucoma patients To determine how to most sensitively and specifically determine progression for a trial of a potential neuroprotective agent.
SECONDARY OBJECTIVES
To evaluate genetic and other potential biomarkers associated with progression in glaucoma.
To evaluate tests currently used on glaucoma patients to better predict which ones are most sensitive to detect disease progression and measure rates of change.
To assess progression by structural and functional tests:
- Optic disc stereophotographs
- Cirrus OCT
- RTVue OCT
- Standard Automated Perimetry (SAP)
- Frequency Doubling Technology Matrix
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Open Angle Glaucoma | – | –• Group A (diagnosis of primary open-angle glaucoma or pseudo-exfoliative glaucoma) - subjects with documented disease progression in the past and high IOP (IOP above target), disc hemorrhage, family history of glaucoma-related vision loss or thin central cornea (<510um), * Progression is confirmed with repeatable abnormal standard automated perimetry (SAP) or progressive glaucomatous optic neuropathy * For patients that have had previous glaucoma surgery, they can be included if they have had documented glaucomatous progression post-surgery * Best corrected visual acuity of 20/40 or better at enrollment |
| Healthy Individuals | – | –• Group B (healthy controls)- healthy subjects without any ophthalmic disease and an IOP < 22mmHg o Normal appearing optic disc and no evidence of optic disc damage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Open Angle Glaucoma Health Individuals
Key inclusion criteria (8 listed)
- Group A (diagnosis of primary open-angle glaucoma or pseudo-exfoliative glaucoma) - subjects with documented disease progression in the past 3 years and high IOP (IOP above target), disc hemorrhage (within 3 years), family history of glaucoma-related vision loss or thin central cornea (<510um),
- Group B (healthy controls)- healthy subjects without any ophthalmic disease and an IOP < 22mmHg
- o Normal appearing optic disc and no evidence of optic disc damage
- Ability to provide written informed consent for participation in this study
Key exclusion criteria (16 listed)
- Subjects with an ocular disease other than glaucoma
- Subjects participating in a long-term interventional clinical trial
- Subjects with any other medical condition which would prohibit them from making all study visits within the 24 months
- Glaucoma patients who have not demonstrated disease progression in the past 3 years
- Patients with diagnosis of pigmentary dispersion syndrome/glaucoma
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
Not reported in the source record.
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 23 Jan 2024.
- Background: PubMed 19376584Medeiros FA, Alencar LM, Zangwill LM, Sample PA, Weinreb RN. The Relationship between intraocular pressure and progressive retinal nerve fiber layer loss in glaucoma. Ophthalmology. 2009 Jun;116(6):1125-33.e1-3. doi: 10.1016/j.ophtha.2008.12.062. Epub 2009 Apr 19.
- Background: PubMed 20541265Medeiros FA, Alencar LM, Sample PA, Zangwill LM, Susanna R Jr, Weinreb RN. The relationship between intraocular pressure reduction and rates of progressive visual field loss in eyes with optic disc hemorrhage. Ophthalmology. 2010 Nov;117(11):2061-6. doi: 10.1016/j.ophtha.2010.02.015. Epub 2010 Jun 11.
- Background: PubMed 19815731Medeiros FA, Zangwill LM, Alencar LM, Bowd C, Sample PA, Susanna R Jr, Weinreb RN. Detection of glaucoma progression with stratus OCT retinal nerve fiber layer, optic nerve head, and macular thickness measurements. Invest Ophthalmol Vis Sci. 2009 Dec;50(12):5741-8. doi: 10.1167/iovs.09-3715. Epub 2009 Oct 8.
- Background: PubMed 20036010Alencar LM, Zangwill LM, Weinreb RN, Bowd C, Vizzeri G, Sample PA, Susanna R Jr, Medeiros FA. Agreement for detecting glaucoma progression with the GDx guided progression analysis, automated perimetry, and optic disc photography. Ophthalmology. 2010 Mar;117(3):462-70. doi: 10.1016/j.ophtha.2009.08.012. Epub 2009 Dec 24.
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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.
Robert Weinreb, MD principal investigator
UCSD Shiley 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 University of California, San Diego 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 8 inclusion and 16 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 23 Jan 2024. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01442896, which also lists 4 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 23 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.