TY - JOUR
T1 - Onset and Progression of Persistent Choroidal Hypertransmission Defects in Intermediate Age-Related Macular Degeneration
T2 - A Novel Clinical Trial Endpoint
AU - Liu, Jeremy
AU - Shen, Mengxi
AU - Laiginhas, Rita
AU - Herrera, Gissel
AU - Li, Jianqing
AU - Shi, Yingying
AU - Hiya, Farhan
AU - Trivizki, Omer
AU - Waheed, Nadia K.
AU - Chung, Carol Y.
AU - Moult, Eric M.
AU - Fujimoto, James G.
AU - Gregori, Giovanni
AU - Rosenfeld, Philip J.
N1 - Publisher Copyright:
© 2023 Elsevier Inc.
PY - 2023/10
Y1 - 2023/10
N2 - Purpose: The appearance and growth of persistent choroidal hypertransmission defects (hyperTDs) detected on en face swept-source optical coherence tomography (SS-OCT) images from eyes with intermediate age-related macular degeneration (iAMD) were studied to determine if they could serve as novel clinical trial endpoints. Design: Post hoc subgroup analysis of a prospective study. Methods: Subjects with iAMD underwent 6 × 6 mm SS-OCT angiography imaging at their baseline and follow-up visits. The drusen volumes were obtained using a validated SS-OCT algorithm. Two graders independently evaluated all en face structural images for the presence of persistent hyperTDs. The number and area of all hyperTDs along with drusen volume were obtained from all SS-OCT angiography scans. Eyes were censored from further follow-up once exudative AMD developed. Results: A total of 171 eyes from 121 patients with iAMD were included. Sixty-eight eyes developed at least 1 hyperTD. Within 1 year after developing a hyperTD, 25% of eyes developed new hyperTDs for an average of 0.44 additional hyperTDs. Over 2 years, as hyperTDs appeared, enlarged, and merged, the average area growth rate was 0.220 mm/yr using the square-root transformation strategy. A clinical trial design using the onset and enlargement of these hyperTDs for the study of disease progression in eyes with iAMD is proposed. Conclusions: The appearance and growth of persistent choroidal hyperTDs in eyes with iAMD can be easily detected and measured using en face OCT imaging and can serve as novel clinical trial endpoints for the study of therapies that may slow disease progression from iAMD to late AMD.
AB - Purpose: The appearance and growth of persistent choroidal hypertransmission defects (hyperTDs) detected on en face swept-source optical coherence tomography (SS-OCT) images from eyes with intermediate age-related macular degeneration (iAMD) were studied to determine if they could serve as novel clinical trial endpoints. Design: Post hoc subgroup analysis of a prospective study. Methods: Subjects with iAMD underwent 6 × 6 mm SS-OCT angiography imaging at their baseline and follow-up visits. The drusen volumes were obtained using a validated SS-OCT algorithm. Two graders independently evaluated all en face structural images for the presence of persistent hyperTDs. The number and area of all hyperTDs along with drusen volume were obtained from all SS-OCT angiography scans. Eyes were censored from further follow-up once exudative AMD developed. Results: A total of 171 eyes from 121 patients with iAMD were included. Sixty-eight eyes developed at least 1 hyperTD. Within 1 year after developing a hyperTD, 25% of eyes developed new hyperTDs for an average of 0.44 additional hyperTDs. Over 2 years, as hyperTDs appeared, enlarged, and merged, the average area growth rate was 0.220 mm/yr using the square-root transformation strategy. A clinical trial design using the onset and enlargement of these hyperTDs for the study of disease progression in eyes with iAMD is proposed. Conclusions: The appearance and growth of persistent choroidal hyperTDs in eyes with iAMD can be easily detected and measured using en face OCT imaging and can serve as novel clinical trial endpoints for the study of therapies that may slow disease progression from iAMD to late AMD.
UR - http://www.scopus.com/inward/record.url?scp=85163845170&partnerID=8YFLogxK
U2 - 10.1016/j.ajo.2023.03.012
DO - 10.1016/j.ajo.2023.03.012
M3 - ???researchoutput.researchoutputtypes.contributiontojournal.article???
C2 - 36958537
AN - SCOPUS:85163845170
SN - 0002-9394
VL - 254
SP - 11
EP - 22
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
ER -