Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03920007 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of Subretinally Injected ATSN-101 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from Atsena Therapeutics Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Results first posted: Aug 3, 2026
    • Secondary endpoints: 3 to 7
    v18
  2. Start date: Sep 12, 2019 to Oct 22, 2019
    • Secondary endpoints revised (3)
    v17
  3. Primary endpoints: 2 to 1
    • Secondary endpoints: 2 to 3
    • Study description shortened, about 42 words
    v16
  4. Interventions: 1% Prednisolone (Drug), Prednisone (Drug), SAR439483 (Drug), SAR439483 Diluent Solution (Drug), Triamcinalone Acetonide (Drug)… to 1% Prednisolone (Drug), ATSN-101 (Drug), ATSN-101 Diluent Solution (Drug), Prednisone (Drug), Triamcinalone Acetonide (Drug)…
    • Eligibility criteria revised
    • Study description revised
    • Study title revised
    v15
  5. Primary completion date changed from estimate of May 26, 2023 to May 19, 2023
    • Study completion date: May 26, 2027 to May 19, 2027
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. Re-verified, no change to tracked fieldsv13
  2. Primary completion date: Feb 2022 to May 26, 2023v12 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Feb 2022 to May 26, 2027
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Site details revised at 2 of 2 sites
  3. Re-verified, no change to tracked fieldsv11
  4. Site contacts updated at 1 of 2 sitesv10
  5. Study sites: 1 to 2v9
  6. Primary completion date: Feb 2021 to Feb 2022v8
  7. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v7
  8. Lead sponsor: Sanofi to Atsena Therapeutics Inc.
    • Study site revised
    v6
  9. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Mar 2021 to Feb 2021
    • Study completion date: Mar 2022 to Feb 2022
    • Site details revised
    v5
  10. Study completion date: Apr 5, 2022 to Mar 2022v4
  11. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Dec 2020 to Mar 2021
    • Study completion date: Dec 2021 to Apr 5, 2022
    • Start date changed from estimate of Jul 25, 2019 to Sep 12, 2019
  12. Primary completion date: Sep 2022 to Dec 2020
    • Study completion date: Sep 2023 to Dec 2021
    • Start date: Jul 9, 2019 to Jul 25, 2019
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Primary Objective: To evaluate the safety and tolerability of ascending doses of ATSN-101 administered as a unilateral subretinal injection in patients with Leber Congenital Amaurosis (LCA) caused by autosomal recessive guanylate cyclase 2D (GUCY2D) mutations (GUCY2D-LCA). Secondary Objective: To evaluate the efficacy of ascending doses of ATSN-101 administered as a unilateral subretinal injection in patients with GUCY2D-LCA.
Trial Details
NCT Number NCT03920007
Lead Sponsor Atsena Therapeutics Inc.
Conditions
(from sponsor)		 Leber Congenital Amaurosis, LCA, LCA1
Related terms Leber Congenital Amaurosis, Retinal cone dystrophy 2
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov