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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by University of California, San Diego
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Cheryl Goodness, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01442896
First received: September 26, 2011
Last updated: September 28, 2011
Last verified: September 2011
  Purpose

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.


Condition
Primary Open Angle Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: STudy to Assess Rapid Disease Progression by Clinical and Genetic Factors In Glaucoma patientS That Are High Risk (STARFISH)

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Estimated Enrollment: 130
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Primary Open Angle Glaucoma
Healthy Individuals

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary Open Angle Glaucoma Health Individuals

Criteria

INCLUSION CRITERIA

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

EXCLUSION CRITERIA

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.
  • Patients with narrow angles in which laser iridotomy is planned or anticipated within the next 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442896

Locations
United States, California
Hamilton Glaucoma Center, UCSD Recruiting
La Jolla, California, United States, 92093
Contact: Eunice Williams-Steppe, MA    858-822-1133    ewsteppe@glaucoma.ucsd.edu   
Contact: Cheryl RudyGoodness, MPH    858-822-1896    cgoodness@glaucoma.ucsd.edu   
Principal Investigator: Robert N Weinreb, MD         
Sub-Investigator: Felipe A Medeiros, MD, PhD         
Sponsors and Collaborators
University of California, San Diego
Genentech
  More Information

Publications:
Responsible Party: Cheryl Goodness, Distinguished Professor of Ophthalmology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01442896     History of Changes
Other Study ID Numbers: 111223
Study First Received: September 26, 2011
Last Updated: September 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Disease Progression
Ocular Hypertension
Eye Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014