Case study

24 Feb 2021

Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration


Overview

TFS was selected to perform full-service clinical operations and project management, including site contracts, ethics submissions, regulatory, and other clinical study start-up activities. Start-up tasks for this study included specialized processes to be undertaken at the site level, such as visual acuity and SD-OCT requiring associated digital systems and certified technicians.

The sponsor is an innovative biopharmaceutical company focused on the discovery and development of treatments for retinal diseases with significant unmet medical needs.


    Study specifics

    Drug class: Pegylated RNA Adapter via intravitreal injection
    Patient population: Aged 50 years or greater
    Countries: US, Canada, Israel, Czech Republic, Hungary, Croatia, Latvia
    Primary endpoints: Mean rate of change in GA over 12 months measured by fundus autofluorescence (FAF) at three time points: Baseline, Month 6 and Month 12
    Study phase: II B
    Number of patients randomized: 286
    Number of Sites: 78
    Treatment period: 18 months

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