Recruiting

Observational Study

Sponsor:

Boston Image Reading Center

Code:

NCT04469140

Conditions

Dry Macular Degeneration

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

SS-OCT imaging

Study Details

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

Study ID

NCT04469140

Start date

Jan 18, 2020

Status verified date

Mar, 2022

Completion date

Aug, 2025

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

SS-OCT imaging

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

Primary outcome measure

  • Change in the Percentage of Choroidal Perfusion Deficits at 1 year compared to Baseline [ Time Frame: 1-year and 2-year time points ]

Central Contacts and Locations

Central contacts

Jen Tourtellot

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

Locations

University of California Los Angeles Doheny Eye Institute

Recruiting

Los Angeles, California, United States, 91105

Principal Investigator:

SriniVas Sadda, MD

Bascom Palmer Eye Institue

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Philip J Rosenfeld, MD, PhD

New England Eye Center/Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Principal Investigator:

Michelle Liang, MD

Vitreous Retina Macular Consultants of NY

Recruiting

New York, New York, United States, 10022

Principal Investigator:

Bailey Freund, MD

More Information

Sponsor

Boston Image Reading Center

Last update posted

Mar 10, 2022

Last verified

Mar, 2022

Keywords

  • AMD
  • Early AMD
  • Intermediate AMD
  • Geographic Atrophy
  • Nascent GA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boston Image Reading Center on 2022-03-10.