Decision: Favourable

Decisions Table

Study Title:

EXPLORE: A PHASE 2, OUTCOMES ASSESSOR-MASKED, MULTICENTRE, RANDOMISED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TWO DOSES OF GT005 ADMINISTERED AS A SINGLE SUBRETINAL INJECTION IN SUBJECTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION.

  • NREC Code:

    21-NREC-CT-128

  • Decision:

    Favourable

  • Meeting Date:

    03/11/2021

  • Study Type:

    CT application

  • Principal Investigator:

    Dr Eugene Ng

  • PI Institution:

    Institute of Eye Surgery, UPMC Whitfield Hospital, Butlerstown, Waterford, X91 DH9W, Ireland

  • Sponsor:

    Gyroscope Therapeutics

EXPLORE: A PHASE 2, OUTCOMES ASSESSOR-MASKED, MULTICENTRE, RANDOMISED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TWO DOSES OF GT005 ADMINISTERED AS A SINGLE SUBRETINAL INJECTION IN SUBJECTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION.

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