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Purpose

This study is being conducted to assess two imaging methods-central microperimetry and radial OCT (Optical Coherence Tomography)-in patients with Geographic Atrophy (GA) or those who are at risk of developing this condition. The study team is trying to determine whether these methods can provide more accurate measurements of GA progression toward the foveal center, the central part of the retina responsible for your sharpest, most detailed vision.

Conditions

Eligibility

Eligible Ages
Over 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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): 1. Non-proliferative diabetic retinopathy involving 10 or more hemorrhages or microaneurysms, or active proliferative diabetic retinopathy 2. Branch or central retinal vein or artery occlusion 3. Macular hole 4. Pathologic myopia 5. Uveitis 6. Pseudovitelliform maculopathy 7. Intraoperative surgery within the last 90 days prior to study eye enrollment

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Non-central geographic atrophy not being treated Patients with age-related macular degeneration who have geographic atrophy that does not involve the fovea.
  • Diagnostic Test: Optical coherence tomography
    High-resolution imaging method used to evaluate the structure of the retina
    Other names:
    • OCT
  • Diagnostic Test: Microperimetry
    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
  • Diagnostic Test: Optical coherence tomography
    High-resolution imaging method used to evaluate the structure of the retina
    Other names:
    • OCT
  • Diagnostic Test: Microperimetry
    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.
  • Diagnostic Test: Optical coherence tomography
    High-resolution imaging method used to evaluate the structure of the retina
    Other names:
    • OCT
  • Diagnostic Test: Microperimetry
    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.
  • Diagnostic Test: Optical coherence tomography
    High-resolution imaging method used to evaluate the structure of the retina
    Other names:
    • OCT
  • Diagnostic Test: Microperimetry
    A functional test that maps retinal sensitivity by measuring how well you can detect lights in different areas of your vision.

Recruiting Locations

University of California, San Francisco
San Francisco, California 94143
Contact:
Jay M Stewart, MD
628-206-3123
eyestudy@ucsf.edu

More Details

NCT ID
NCT07556406
Status
Recruiting
Sponsor
University of California, San Francisco

Study Contact

Jay M Stewart, MD
(628) 206-3123
eyestudy@ucsf.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center