Onset and Progression of Persistent Choroidal Hypertransmission Defects in Intermediate Age-Related Macular Degeneration: A Novel Clinical Trial Endpoint

Jeremy Liu, Mengxi Shen, Rita Laiginhas, Gissel Herrera, Jianqing Li, Yingying Shi, Farhan Hiya, Omer Trivizki, Nadia K. Waheed, Carol Y. Chung, Eric M. Moult, James G. Fujimoto, Giovanni Gregori, Philip J. Rosenfeld*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)11-22
Number of pages12
JournalAmerican Journal of Ophthalmology
Volume254
DOIs
StatePublished - Oct 2023
Externally publishedYes

Funding

FundersFunder number
Carl Zeiss Meditec, Chengdu Kanghong Biotech
Carl Zeiss Meditec, Inc
Carl Zeiss Meditec, Inc.
Gyroscope Therapeutics
National Eye Institute CenterR01-EY011289-36, P30EY014801
Ocunexus Therapeutics
Olix Therapeutics
Stealth BioTherapeutics
Boehringer Ingelheim
Research to Prevent Blindness
Alexion Pharmaceuticals
University of Miami
Massachusetts Institute of Technology
Salah Foundation

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