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A Phase 1/2 Dose Escalation Study of Subretinally Injected ATSN-101 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D

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Trial Profile

A Phase 1/2 Dose Escalation Study of Subretinally Injected ATSN-101 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 06 Sep 2024

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At a glance

  • Drugs ATSN 101 (Primary) ; Prednisolone; Prednisone; Triamcinolone; Trimethoprim/polymixin B
  • Indications Leber congenital amaurosis
  • Focus Adverse reactions; Proof of concept
  • Sponsors Atsena Therapeutics; Sanofi

Most Recent Events

  • 05 Sep 2024 According to an Atsena Therapeutics media release, the data of this trial was publised in The Lancet
  • 16 Jan 2024 According to an Atsena Therapeutics media release, Positive 12-month safety and efficacy data from this trial will be presented at the 47th Annual Macula Society Meeting, which is being held February 7-10, 2024, in Palm Springs, CA.
  • 16 Jan 2024 According to an Atsena Therapeutics media release, company announced that U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to ATSN-101 Gene Therapy for GUCY2D-associated Leber Congenital Amaurosis (LCA1).

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