Non Exudative AMD Imaged With SS-OCT

Overview

The investigators wish to better understand the role of the choriocapillaris (CC) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the CC could prove useful as an anatomic clinical trial endpoint in future drug trials.

Full Title of Study: “Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2022

Detailed Description

This is a longitudinal observational study where the investigators will look at 450 subjects, 200 with intermediate AMD in at least one eye, or with AMD in one eye, either early or intermediate, and with late AMD (exudative) in the other eye, and 250 subjects with nGA or GA in at least one eye.

Interventions

  • Device: SS-OCT imaging
    • All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument

Arms, Groups and Cohorts

  • Cohort 1 ‘IMPACT Cohort’
    • Subjects with intermediate AMD in both eyes, and at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR subjects with AMD (early or intermediate) diagnosed in one eye and exudative AMD diagnosed in the fellow eye will undergo SS-OCT imaging every 3 months for 2 years
  • Cohort 2 ‘SWAGGER Cohort’
    • Subjects with GA or nGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye will undergo SS-OCT imaging every 3 months for 2 years
  • Cohort 3
    • Subjects with GA enrolled in another trial

Clinical Trial Outcome Measures

Primary Measures

  • Change in Choroidal Perfusion Deficits at 1 year compared to Baseline
    • Time Frame: 1 year time point
    • Assessment of Choriocapillaris perfusion

Secondary Measures

  • Pre-existing sub-clinical Macular Neovascularization (MNV)
    • Time Frame: 1 year and 2-year time points
    • Presence of abnormal new vessels arising from the Choroid
  • Automated Drusen Volume measurements
    • Time Frame: 1 year and 2-year time points
    • Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers
  • Automated GA measurements
    • Time Frame: 1 year and 2-year time points
    • Compare the automated measurements of GA area using the Zeiss algorithm with manual measurements by trained readers
  • Structural OCT markers and Genetic Markers
    • Time Frame: 1 year and 2-year time points
    • Correlate structural markers on SS-OCT/OCTA with genetic markers of disease

Participating in This Clinical Trial

Inclusion Criteria

1. Aged 50 and over

2. Clinic diagnosis of non-exudative iAMD in at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02 mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR Clinical diagnosis of early or early/intermediate stage AMD in one eye in the absence of nGA or GA and exudative AMD in the other eye OR clinical diagnosis of GA or nGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye which has never been treated with anti-VEGF agents

3. Willing and able to comply with clinic visits and study-related procedures

4. Provide signed informed consent

Exclusion Criteria

A subject who meets any of the following criteria will be excluded from the study:

1. Below the age of 50

2. Subjects with exudative AMD in both eyes

3. Eyes with evidence of non-proliferative and proliferative diabetic retinopathy.

4. Presence of confounding ocular diagnosis such as myopia >6D, or other ocular conditions that may cause retinal pigment epithelium atrophy or exudative MNV

5. Subjects unable to give informed consent.

6. Subjects who are unable to comply with imaging guidelines

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boston Image Reading Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nadia Waheed, MD, Principal Investigator, Boston Image Reading Center/Tufts Medical Center
    • Philip Rosenfield, MD, PhD, Principal Investigator, Bascom Palmer Eye Institute
  • Overall Contact(s)
    • Jen Tourtellot, 1-855-535-BIRC (2472), admin@bostonimagereadingcenter.com

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