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Improving the Feasibility of Glaucoma Clinical Trials Using Trend-Based Visual Field Progression Endpoints
Zhichao Wu1,2,3,4, David P Crabb5, Balwantray C Chauhan6
1Duke Eye Center and Department of Ophthalmology, Duke University School of Medicine, Durham, North Carolina.
Ophthalmology. Glaucoma
|July 8, 2020
Summary
Trend-based analyses significantly reduce sample size for glaucoma clinical trials, making them more feasible. Evaluating visual field change rates improves trial efficiency compared to event-based methods.
Area of Science:
- Ophthalmology
- Clinical Trials
- Statistical Analysis
Background:
- Glaucoma is a slowly progressive disease, posing challenges for short-term clinical trials.
- Traditional visual field endpoints often necessitate large sample sizes, impacting trial feasibility.
Purpose of the Study:
- To determine sample size requirements for glaucoma clinical trials using event-based analyses.
- To assess if trend-based analyses can reduce sample size requirements compared to event-based methods.
Main Methods:
- Computer simulations were used to reconstruct visual fields and estimate variability and rates of change.
- Simulated 2-year clinical trials evaluated treatment efficacy using point-wise event-based progression and linear mixed models (LMMs) for mean deviation (MD) change.
Main Results:
- Trend-based analyses using LMMs reduced sample size requirements by 85-90% compared to event-based analyses.
- For a treatment halting progression in 30% of participants, LMMs required 277 participants/group versus 1924 for event-based analysis.
Conclusions:
- Evaluating the rate of visual field change between groups substantially improves the feasibility of future glaucoma clinical trials.
- Trend-based analyses offer a more efficient approach to sample size determination in glaucoma research.
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