White Paper

Rethinking Strategies For Rescue Treatment In Wet AMD And Retinal Vascular Disease Clinical Trials

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Long-acting anti-VEGF therapies are reshaping how wet age-related macular degeneration (AMD) and retinal vascular disease trials are designed — but every trial testing a longer-lasting treatment still needs a plan for rescuing participants whose disease starts to progress. Getting that plan right is harder than it sounds: rescue criteria must be sensitive enough to catch real disease activity before vision is threatened, yet specific enough to avoid mistaking normal visit-to-visit variability for true worsening. The choices involved — which drug to use for rescue, what changes in vision or retinal thickness should trigger it, which baseline to measure against, when monitoring should begin, and how often participants should be checked — don't just protect participants. They directly shape how a trial's durability and efficacy results are measured and interpreted downstream.

This piece walks through the five core elements of a well-designed rescue strategy and how each one influences outcome measures such as time to first rescue, annualized injection reduction, and the proportion of participants remaining supplemental-injection-free. For trial teams weighing how to balance participant safety with a clean, defensible read on their investigational product's durability, working through these design decisions early is essential to building a rescue strategy that holds up under scrutiny.

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