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A Second Phase 3 non-inferiority Clinical trial of CLS-AX in wet AMD (Wet-age-related-macular-degeneration)

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Trial Profile

A Second Phase 3 non-inferiority Clinical trial of CLS-AX in wet AMD (Wet-age-related-macular-degeneration)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2025

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At a glance

  • Drugs Axitinib (Primary)
  • Indications Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 27 Mar 2025 According to a Clearside Biomedical media release, company announced completion of an End-of-Phase 2 meeting with the FDA and alignment on Phase 3 plans for suprachoroidal CLS-AX in wet AMD.The meeting and formal minutes confirmed key elements of the proposed pivotal Phase 3 program, including agreement on the protocol design of two non-inferiority trials, patient population, primary and secondary endpoints, and use of sham injections.
  • 10 Mar 2025 New trial record

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