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A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects With Choroideremia Previously Treated With Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1) and in Subjects With X-Linked Retinitis Pigmentosa Previously Treated With Adeno-Associated Viral Vector Encoding RPGR (AAV8-RPGR) in an Antecedent Study

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Trial Profile

A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects With Choroideremia Previously Treated With Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1) and in Subjects With X-Linked Retinitis Pigmentosa Previously Treated With Adeno-Associated Viral Vector Encoding RPGR (AAV8-RPGR) in an Antecedent Study

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Sep 2023

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At a glance

  • Drugs Cotoretigene toliparvovec (Primary) ; Timrepigine emparvovec (Primary)
  • Indications Choroideraemia
  • Focus Adverse reactions; Registrational
  • Acronyms SOLSTICE
  • Sponsors Biogen; NightstaRx
  • Most Recent Events

    • 05 May 2023 Planned End Date changed from 23 Mar 2027 to 4 Jun 2026.
    • 05 May 2023 Planned primary completion date changed from 23 Mar 2027 to 4 Jun 2026.
    • 26 Oct 2021 Study model changed from cohort to parallel. Treatments section has been updated to capture Participants previously treated with sub-retinal injection of BIIB111 in antecedent studies 273CH301 (NCT03496012) and 273CH203 (NCT03507686). Participants from some other related studies may also be enrolled in this follow-up study.
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