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A Phase III, Multi-Center, Randomized, Double-Masked, Sham Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Trial Profile

A Phase III, Multi-Center, Randomized, Double-Masked, Sham Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Suspended
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2018

At a glance

  • Drugs APL 2 (Primary)
  • Indications Dry macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms OAKS
  • Sponsors Apellis Pharmaceuticals
  • Most Recent Events

    • 20 Dec 2018 According to an Apellis Pharmaceuticals media release, the company expects to be able to restart enrollment of its two phase 3 geographic atrophy trials (DERBY and OAKS) in Q2 2019 and to have fully enrolled both studies by the end of Q1 2020, within the originally planned timeline for completion.
    • 20 Dec 2018 According to an Apellis Pharmaceuticals media release, in non-clinical testing, treatment with API manufactured through the improved manufacturing process did not cause inflammation.Finally, prior to introduction in the phase 3 clinical trials (DERBY and OAKS), new lots of API may first be introduced in a small Phase 1b study of patients with GA with low vision (DERBY and OAKS).
    • 20 Dec 2018 According to an Apellis Pharmaceuticals media release, a new lot of API incorporating these improvements has been manufactured and is ready for release in a quantity sufficient to complete both the DERBY and OAKS Phase 3 clinical trials. The Company believes that the improved manufacturing process can be used to supply API at a scale required for global commercialization.
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