Validating Trend-Based End Points for Neuroprotection Trials in Glaucoma.

ABSTRACT:

Purpose

The purpose of this study was to evaluate the power of trend-based visual field (VF) progression end points against long-term development of event-based end points accepted by the US Food and Drug Administration (FDA).

Methods

One eye from 3352 patients with ≥10 24-2 VFs (median = 11 years) follow-up were analyzed. Two FDA-compatible criteria were applied to these series to label "true-progressed" eyes: ≥5 locations changing from baseline by more than 7 dB (FDA-7) or by more than the expected test-retest variability (GPA-like) in 2 consecutive tests. Observed rates of progression (RoP) were used to simulate trial-like series (2 years) randomly assigned (1000 times) to a "placebo" or a "treatment" arm. We simulated neuroprotective "treatment" effects by changing the p

SUBMITTER: Montesano G 

PROVIDER: S-EPMC10619697 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature