Non Exudative AMD Imaged With SS-OCT- Extension

a study on Macular Degeneration Geographic Atrophy

Summary

Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by SriniVas Sadda, MD

Description

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.

Official Title

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

Details

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).

Keywords

Dry Macular Degeneration, AMD, Early AMD, Intermediate AMD, Geographic Atrophy, Nascent GA, Macular Degeneration, SS-OCT imaging

Eligibility

You can join 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 CAN'T join 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

Locations

  • University of California Los Angeles Doheny Eye Institute accepting new patients
    Los Angeles California 91105 United States
  • Bascom Palmer Eye Institue accepting new patients
    Miami Florida 33136 United States

Lead Scientist at UCLA

  • SriniVas Sadda, MD
    Srinivas Sadda, M.D., holds the A. Ray Irvine, Jr., MD, Endowed Chair in Clinical Ophthalmology.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Image Reading Center
ID
NCT04469140
Study Type
Observational
Participants
Expecting 450 study participants
Last Updated