- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07556406
Central micrOperimetry and Radial OCT Evaluation in Geographic Atrophy (CORE-GA): a Prospective Pilot Study (CORE-GA)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jay M Stewart, MD
- Phone Number: (628) 206-3123
- Email: eyestudy@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- Recruiting
- University of California, San Francisco
-
Contact:
- Jay M Stewart, MD
- Phone Number: 628-206-3123
- Email: eyestudy@ucsf.edu
-
Principal Investigator:
- Jay M Stewart, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects must be 55+ years of age Subjects in the "Intermediate AMD Observation Arm" must have intermediate age-related macular degeneration in one eye
Subjects in the "GA Observation Arm", "GA Continuing Treatment Arm", and "GA Treatment Arm" must have non-central GA (defined as GA has not involved the center point of the fovea) and at least 1% GA in the central 1 mm zone.
Exclusion Criteria:
- Subjects with central involvement of GA. Central involvement is defined as geographic atrophy involving the foveal center point.
Subjects with a baseline size of GA > 17.5mm2 (7.0 Macular Photocoagulation Study Disc Areas).
Subjects who are: pregnant women, adults who cannot consent for themselves, and those who use alcohol in excess. Excess alcohol use is defined by binge drinking (pattern of drinking that brings blood alcohol concentration levels to 0.08 g/dL) on 5 or more days in the past month.
Evidence of retinal atrophy due to causes other than atrophic AMD. Subjects who have had anti-VEGF injections or active choroidal neovascularization in the study eye during the last 12 months Current evidence or history of ocular disorders in the study eye that in the opinion of the investigator confounds study outcome measures, including (but not limited to):
- Non-proliferative diabetic retinopathy involving 10 or more hemorrhages or microaneurysms, or active proliferative diabetic retinopathy
- Branch or central retinal vein or artery occlusion
- Macular hole
- Pathologic myopia
- Uveitis
- Pseudovitelliform maculopathy
- Intraoperative surgery within the last 90 days prior to study eye enrollment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-central geographic atrophy not being treated
Patients with age-related macular degeneration who have geographic atrophy that does not involve the fovea.
|
High-resolution imaging method used to evaluate the structure of the retina
Other Names:
A functional test that maps retinal sensitivity by measuring how well you can detect lights in different areas of your vision.
|
|
Intermediate age-related macular degeneration
Patients with intermediate age-related macular degeneration
|
High-resolution imaging method used to evaluate the structure of the retina
Other Names:
A functional test that maps retinal sensitivity by measuring how well you can detect lights in different areas of your vision.
|
|
Non-central geographic atrophy currently being treated
Patients with non-central geographic atrophy from age-related macular degeneration who are currently receiving treatment for this condition.
|
High-resolution imaging method used to evaluate the structure of the retina
Other Names:
A functional test that maps retinal sensitivity by measuring how well you can detect lights in different areas of your vision.
|
|
Non-central geographic atrophy initiating treatment
Patients with non-central geographic atrophy from age-related macular degeneration who will be starting to receive treatment for this condition.
|
High-resolution imaging method used to evaluate the structure of the retina
Other Names:
A functional test that maps retinal sensitivity by measuring how well you can detect lights in different areas of your vision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Geographic atrophy progression rate
Time Frame: 1 year
|
Quantify the progression rate of geographic atrophy toward the foveal center over time
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Longitudinal progression of macular sensitivity over time
Time Frame: 1 year
|
Measure macular sensitivity over time.
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jay Stewart, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-43635
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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