STudy to Assess Rapid Disease Progression by Clinical and Genetic Factors In Glaucoma patientS That Are High Risk

NCT01442896 | Completed

• 1 other identifier: 111223
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Open Angle Glaucoma

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Open Angle Glaucoma Health Individuals

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Hamilton Glaucoma Center, UCSD

La Jolla, California, 92093, United States

Location

Related Publications (4)

• 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.

  PMID: 19376584 BACKGROUND

• Medeiros 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.

  PMID: 20541265 BACKGROUND

• Medeiros 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.

  PMID: 19815731 BACKGROUND

• Alencar 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.

  PMID: 20036010 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

All patients will also have blood samples drawn for genetic analysis and potential biomarker testing at Day 0 or at another visit during the study.

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Robert Weinreb, MD

  UCSD Shiley Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman & Professor of Ophthalmology

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 29, 2011
• Study Start: September 1, 2011
• Primary Completion: December 18, 2015
• Study Completion: December 18, 2015
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

US (1)