Non Exudative AMD Imaged With SS-OCT- Extension (BIRC-02)

Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography: The Extension Study

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Macular Degeneration
• Intervention / Treatment: Device: SS-OCT imaging

Detailed Description

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. This is an extension of a currently ongoing longitudinal observational study (BIRC-01) (NCT03688243).

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Jen Tourtellot; Phone Number: 1-855-535-BIRC (2472); Email: admin@bostonimagereadingcenter.com

Study Locations

• Australia
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Recruiting
      • Melbourne University CERA
      • Contact: Emily Caruso
      • Principal Investigator: Robyn Guymer, MD
• United States
  • California
    • Los Angeles, California, United States, 91105
      • Recruiting
      • University of California Los Angeles Doheny Eye Institute
      • Contact: Janett Mendez
      • Principal Investigator: SriniVas Sadda, MD
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Bascom Palmer Eye Institue
      • Contact: Monica Arango
      • Principal Investigator: Philip J Rosenfeld, MD, PhD
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • New England Eye Center/Tufts Medical Center
      • Contact: Nancy Gee, MPH
      • Principal Investigator: Michelle Liang, MD
  • New York
    • New York, New York, United States, 10022
      • Recruiting
      • Vitreous Retina Macular Consultants of NY
      • Contact: Renata Salgado
      • Principal Investigator: Bailey Freund, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with intermediate AMD, Geographic Atrophy and nascent Geographic Atrophy and who have completed the BIRC-01 study

Description

Inclusion Criteria:

• Enrollment in and completion of the BIRC-01 study
• 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
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent

Exclusion Criteria:

• Subjects with exudative AMD in both eyes
• Eyes with evidence of non-proliferative and proliferative diabetic retinopathy.
• Presence of confounding ocular diagnosis such as myopia >6D, or other ocular conditions that may cause retinal pigment epithelium atrophy or exudative MNV
• Subjects currently or previously enrolled in other interventional clinical trials in which treatment was administered to the study eye.
• Previous vitrectomy or intravitreal injections in the study eye.
• Axial length measurement ≥ 26 mm.
• Subjects unable to give informed consent.
• Subjects who are unable to comply with imaging guidelines

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Percentage of Choroidal Perfusion Deficits at 1 year compared to Baseline	Compare the percentage of choroidal perfusion deficits as measured using automated algorithms	1-year and 2-year time points

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-existing and new sub-clinical Macular Neovascularization (MNV)	Identify the number of abnormal new vessels arising from the Choroid at Baseline, 1-year and 2-year time points	1-year and 2-year time points
Automated Drusen Volume measurements	Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers	1-year and 2-year time points
Automated Geography Atrophy measurements	Compare the automated measurements of Geography Atrophy area using the Zeiss algorithm with manual measurements by trained readers	1-year and 2-year time points
Choroidal Thickness (millimeters)	Correlate Choroidal Thickness measurements (millimeters) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates	1-year and 2-year time points
Choroidal Vascularity Index (percentage)	Correlate Choroidal Vascularity Index (percentage) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates	1-year and 2-year time points

Collaborators and Investigators

• Sponsor: Boston Image Reading Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2020
• Primary Completion (ANTICIPATED): August 1, 2025
• Study Completion (ANTICIPATED): August 1, 2025

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (ACTUAL): July 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: AMD; Geographic Atrophy; Early AMD; Intermediate AMD; Nascent GA
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Geographic Atrophy
• Other Study ID Numbers: BIRC-02 IMPACT SWAGGER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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