timrepigene emparvovec (BIIB111) / Biogen 
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 1 Disease   2 Trials   2 Trials   29 News 
  • ||||||||||  timrepigene emparvovec (BIIB111) / Biogen
    P2 data, Journal, Gene therapy:  An Open-Label Phase II Study Assessing the Safety of Bilateral, Sequential Administration of Retinal Gene Therapy in Participants with Choroideremia: The GEMINI Study. (Pubmed Central) -  Aug 16, 2024   
    P2
    GEMINI was a multicenter, open-label, prospective, two-period, interventional Phase II study assessing the safety of bilateral sequential administration of timrepigene emparvovec, a gene therapy, in adult males with genetically confirmed choroideremia (NCT03507686, ClinicalTrials.gov)...Presence of anti-vector neutralizing antibodies at baseline was potentially associated with a higher percentage of TEAEs related to ocular inflammation or reduced visual acuity after injection of the first eye. The GEMINI study results may inform decisions regarding bilateral sequential administration of other gene therapies for retinal diseases.
  • ||||||||||  timrepigene emparvovec (BIIB111) / Biogen
    Trial completion date, Trial primary completion date, Gene therapy, Viral vector:  GEMINI: A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111 (clinicaltrials.gov) -  Mar 18, 2022   
    P2,  N=60, Active, not recruiting, 
    Active, not recruiting --> Completed Trial completion date: Feb 2022 --> Jun 2022 | Trial primary completion date: Feb 2022 --> Jun 2022
  • ||||||||||  timrepigene emparvovec (BIIB111) / Biogen
    Trial completion, Gene therapy, Viral vector:  STAR: Efficacy and Safety of BIIB111 for the Treatment of Choroideremia (clinicaltrials.gov) -  Dec 23, 2020   
    P3,  N=170, Completed, 
    N=100 --> 440 | Trial completion date: Apr 2024 --> Mar 2027 | Trial primary completion date: Apr 2024 --> Mar 2027 Active, not recruiting --> Completed
  • ||||||||||  timrepigene emparvovec (BIIB111) / Biogen
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Gene therapy, Viral vector:  GEMINI: A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111 (clinicaltrials.gov) -  Feb 24, 2020   
    P2,  N=60, Active, not recruiting, 
    Active, not recruiting --> Completed Recruiting --> Active, not recruiting | N=15 --> 60 | Trial completion date: Mar 2020 --> Feb 2022 | Trial primary completion date: Mar 2020 --> Feb 2022
  • ||||||||||  timrepigene emparvovec (BIIB111) / Biogen
    Enrollment closed, Trial completion date, Trial primary completion date, Gene therapy, Viral vector:  STAR: Efficacy and Safety of BIIB111 for the Treatment of Choroideremia (clinicaltrials.gov) -  Jan 13, 2020   
    P3,  N=169, Active, not recruiting, 
    Recruiting --> Active, not recruiting | N=15 --> 60 | Trial completion date: Mar 2020 --> Feb 2022 | Trial primary completion date: Mar 2020 --> Feb 2022 Recruiting --> Active, not recruiting | Trial completion date: Mar 2020 --> Nov 2020 | Trial primary completion date: Mar 2020 --> Nov 2020