Video: Fellow Eye Data Supports GA Clinical Trial Design

At ASRS, Diana Do, MD, presented results of a post hoc analysis of the OAKS and DERBY trials of geographic atrophy growth rates in untreated eyes vs sham eyes.

By: Diana V. Do, MD, Roger A. Goldberg, MD, MBA

Retinal Physician August 9, 2025

Clinical Report: Fellow Eye Data Supports GA Clinical Trial Design

Overview

A post hoc analysis of the OAKS and DERBY trials indicates that fellow eyes in patients with bilateral geographic atrophy (GA) exhibit growth rates similar to sham-treated eyes. This finding supports the use of fellow eyes as internal controls in clinical trials, enhancing the validity of projected sham models.

Background

Geographic atrophy is a significant cause of vision loss in age-related macular degeneration. Understanding the growth patterns of GA lesions is crucial for designing effective clinical trials and developing therapeutic strategies. The ability to use fellow eyes as controls could improve trial efficiency and the reliability of treatment efficacy assessments.

Data Highlights

No numerical data available in the provided source.

Key Findings

Fellow eyes in patients with bilateral GA grow at rates comparable to sham-treated eyes.
This supports the validity of using fellow eyes as internal controls in clinical trials.
The analysis validates projected sham models used in long-term studies like GALE.
Pegcetacoplan treatment shows increasing efficacy over time, suggesting earlier intervention may be beneficial.
Safety concerns include rare cases of retinal vasculitis associated with pegcetacoplan treatment.

Clinical Implications

Clinicians should consider the implications of using fellow eyes as controls in GA trials, as this may enhance the reliability of trial outcomes. Additionally, early intervention with pegcetacoplan could lead to better preservation of retinal function in patients with GA.

Conclusion

The findings from the fellow eye analysis provide important insights for the design of future clinical trials in geographic atrophy, emphasizing the potential for improved treatment strategies.

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Retinal Physician