Non Exudative AMD Imaged With SS-OCT (BIRC-01)

Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography

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: Active, not recruiting
• Conditions: Dry Macular Degeneration
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Melbourne University CERA
• United States
  • California
    • Los Angeles, California, United States, 91105
      • University of California Los Angeles Doheny Eye Institute
  • Florida
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institue
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • New England Eye Center/Tufts Medical Center
  • New York
    • New York, New York, United States, 10022
      • Vitreous Retina Macular Consultants of NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• 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.

Description

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

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 Choroidal Perfusion Deficits at 1 year compared to Baseline	Assessment of Choriocapillaris perfusion	1 year time point

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-existing sub-clinical Macular Neovascularization (MNV)	Presence of abnormal new vessels arising from the Choroid	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 GA measurements	Compare the automated measurements of GA area using the Zeiss algorithm with manual measurements by trained readers	1 year and 2-year time points
Structural OCT markers and Genetic Markers	Correlate structural markers on SS-OCT/OCTA with genetic markers of disease	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, 2018
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 28, 2018

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; intermediate AMD; early AMD; nascent GA
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Geographic Atrophy
• Other Study ID Numbers: BIRC-01 IMPACT

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