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BIRC-01: Non Exudative AMD Imaged With SS-OCT

Sponsor
Boston Image Reading Center (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03688243
Collaborator
(none)
225
Enrollment
5
Locations
61.4
Anticipated Duration (Months)
45
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SS-OCT imaging

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.

Study Design

Study Type:
Observational
Actual Enrollment :
225 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography
Actual Study Start Date :
Jan 18, 2018
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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

Device: SS-OCT imaging
All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
Other Names:
  • Zeiss PlexElite
  • PlexElite 9000
  • Swept Source OCT
  • Optical Coherence Tomography Angiography

    		•
    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

    Device: SS-OCT imaging
    All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
    Other Names:
  • Zeiss PlexElite
  • PlexElite 9000
  • Swept Source OCT
  • Optical Coherence Tomography Angiography

    		•
    Cohort 3

    Subjects with GA enrolled in another trial

    Device: SS-OCT imaging
    All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
    Other Names:
  • Zeiss PlexElite
  • PlexElite 9000
  • Swept Source OCT
  • Optical Coherence Tomography Angiography

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Choroidal Perfusion Deficits at 1 year compared to Baseline [1 year time point]

      Assessment of Choriocapillaris perfusion

    Secondary Outcome Measures

    1. Pre-existing sub-clinical Macular Neovascularization (MNV) [1 year and 2-year time points]

      Presence of abnormal new vessels arising from the Choroid

    2. Automated Drusen Volume measurements [1 year and 2-year time points]

      Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers

    3. Automated GA measurements [1 year and 2-year time points]

      Compare the automated measurements of GA area using the Zeiss algorithm with manual measurements by trained readers

    4. Structural OCT markers and Genetic Markers [1 year and 2-year time points]

      Correlate structural markers on SS-OCT/OCTA with genetic markers of disease

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California Los Angeles Doheny Eye Institute Los Angeles California United States 91105
    2 Bascom Palmer Eye Institue Miami Florida United States 33136
    3 New England Eye Center/Tufts Medical Center Boston Massachusetts United States 02111
    4 Vitreous Retina Macular Consultants of NY New York New York United States 10022
    5 Melbourne University CERA East Melbourne Victoria Australia 3002

    Sponsors and Collaborators

    • Boston Image Reading Center

    Investigators

    • Principal Investigator: Nadia Waheed, MD, Boston Image Reading Center/Tufts Medical Center
    • Principal Investigator: Philip Rosenfield, MD, PhD, Bascom Palmer Eye Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston Image Reading Center
    ClinicalTrials.gov Identifier:
    NCT03688243
    Other Study ID Numbers:
    • BIRC-01 IMPACT
    • NCT03972800
    First Posted:
    Sep 28, 2018
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Boston Image Reading Center
    AMD
    early AMD
    intermediate AMD
    Geographic Atrophy
    nascent GA
    Additional relevant MeSH terms:
    Macular Degeneration
    Geographic Atrophy

    Study Results

    No Results Posted as of Mar 10, 2022