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

& BULL; PURPOSE: The appearance and growth of persis-tent choroidal hypertransmission defects (hyperTDs) de-tected on en face swept-source optical coherence tomog-raphy (SS-OCT) images from eyes with intermediate age-related macular degeneration (iAMD) were studied to de -termine if they could serve as novel clinical trial end-points. & BULL; DESIGN: Post hoc subgroup analysis of a prospective study. & BULL; METHODS: Subjects with iAMD underwent 6 x 6 mm SS-OCT angiography imaging at their baseline and follow-up visits. The drusen volumes were obtained us-ing a validated SS-OCT algorithm. Two graders indepen-dently evaluated all en face structural images for the pres-ence 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. & BULL; 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 transforma-tion 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. & BULL; CONCLUSIONS: The appearance and growth of persis-tent 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. (Am J Ophthalmol 2023;254: 11-22. & COPY; 2023 Elsevier Inc. All rights reserved.)

Automated summary

This study investigated the appearance and growth of persistent choroidal hypertransmission defects (hyperTDs) in eyes with intermediate age-related macular degeneration (iAMD) using en face swept-source optical coherence tomography (SS-OCT). The results suggests that hyperTDs can serve as novel clinical trial endpoints for the study of therapies that may slow disease progression from iAMD to late AMD. The research proposed a clinical trial design using the onset and enlargement of hyperTDs for the study of disease progression in eyes with iAMD.