Clinical trial NCT04469140: Non Exudative AMD Imaged With SS-OCT- Extension
Official title: Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography: The Extension Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dry Macular Degeneration
Keywords: AMD
Early AMD
Intermediate AMD
Geographic Atrophy
Nascent GA
Lead sponsor: Boston Image Reading Center
Sponsor class: INDUSTRY
First posted: 2020-07-13
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Percentage of Choroidal Perfusion Deficits at 1 year compared to Baseline
timeFrame: 1-year and 2-year time points
Secondary outcomes:
measure: Pre-existing and new sub-clinical Macular Neovascularization (MNV)
timeFrame: 1-year and 2-year time points
measure: Automated Drusen Volume measurements
timeFrame: 1-year and 2-year time points
measure: Automated Geography Atrophy measurements
timeFrame: 1-year and 2-year time points
measure: Choroidal Thickness (millimeters)
timeFrame: 1-year and 2-year time points
measure: Choroidal Vascularity Index (percentage)
timeFrame: 1-year and 2-year time points
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles Doheny Eye Institute
state: California
city: Miami
country: United States
facility: Bascom Palmer Eye Institue
state: Florida
city: Boston
country: United States
facility: New England Eye Center/Tufts Medical Center
state: Massachusetts
city: New York
country: United States
facility: Vitreous Retina Macular Consultants of NY
state: New York
city: East Melbourne
country: Australia
facility: Melbourne University CERA
state: Victoria
Study officials:
affiliation: Boston Image Reading Center/Tufts Medical Center
name: Nadia Waheed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bascom Palmer Eye Institute
name: Philip Rosenfield, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: