Non Exudative AMD Imaged With SS-OCT- Extension

NCT04469140 | Unknown FDA Device

• 1 other identifier: BIRC-02 IMPACT SWAGGER
• Study Type: observational
• Target: 450
• Locations: 2 countries
• Sites: 5

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.

Conditions

Dry Macular Degeneration

Keywords

AMD; Early AMD; Intermediate AMD; Geographic Atrophy; Nascent GA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pre-existing and new sub-clinical Macular Neovascularization (MNV)

  1-year and 2-year time points

• Automated Drusen Volume measurements

  1-year and 2-year time points

• Automated Geography Atrophy measurements

  1-year and 2-year time points

• Choroidal Thickness (millimeters)

  1-year and 2-year time points

• Choroidal Vascularity Index (percentage)

  1-year and 2-year time points

Study Arms (3)

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

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

Cohort 3

Subjects with GA enrolled in another trial

Device: SS-OCT imaging

Interventions

SS-OCT imaging DEVICE

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

Also known as: Zeiss PlexElite, PlexElite 9000, Swept Source OCT, Optical Coherence Tomography Angiography

Cohort 1 'IMPACT Cohort'; Cohort 2 'SWAGGER Cohort'; Cohort 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Image Reading Center: lead

Study Sites (5)

University of California Los Angeles Doheny Eye Institute

Los Angeles, California, 91105, United States

RECRUITING

Bascom Palmer Eye Institue

Miami, Florida, 33136, United States

RECRUITING

New England Eye Center/Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Vitreous Retina Macular Consultants of NY

New York, New York, 10022, United States

RECRUITING

Melbourne University CERA

East Melbourne, Victoria, 3002, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

At baseline or follow up, an optional blood sample for future exploratory genetics analysis will be collected if not already collected during the BIRC-01 study

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Nadia Waheed, MD

  Boston Image Reading Center/Tufts Medical Center

  PRINCIPAL INVESTIGATOR

• Philip Rosenfield, MD, PhD

  Bascom Palmer Eye Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jen Tourtellot

CONTACT

1-855-535-BIRC (2472); admin@bostonimagereadingcenter.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 13, 2020
• Study Start: January 18, 2020
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

AU (1); US (4)