deltatrials
Completed PHASE1 INTERVENTIONAL 3-arm NCT00516477

Safety Study in Subjects With Leber Congenital Amaurosis

A Phase 1 Safety Study in Subjects With Leber Congenital Amaurosis (LCA) Using Adeno-Associated Viral Vector to Deliver the Gene for Human RPE65 Into the Retinal Pigment Epithelium (RPE) [AAV2-hRPE65v2-101]

Sponsor: Spark Therapeutics, Inc.

Updated 11 times since 2017 Last updated: Oct 30, 2020 Started: Sep 30, 2007 Primary completion: Mar 20, 2018 Completion: Mar 20, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Leber Congenital Amaurosis and is currently completed. Spark Therapeutics, Inc. leads this study, which shows 11 recorded versions since 2007 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshotActive Not Recruiting~Apr 2017 – ~Apr 2018 · 12 months · monthly snapshotActive Not Recruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Aug 2019 · 14 months · monthly snapshotActive Not Recruiting~Aug 2019 – ~Dec 2020 · 16 months · monthly snapshotActive Not Recruiting~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshotCompleted~Jan 2021 – ~Apr 2024 · 39 months · monthly snapshotCompleted~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Apr 2024 [monthly]

    Completed PHASE1

  5. Dec 2020 — Jan 2021 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

Show 6 earlier versions
  1. Aug 2019 — Dec 2020 [monthly]

    Active Not Recruiting PHASE1

  2. Jun 2018 — Aug 2019 [monthly]

    Active Not Recruiting PHASE1

  3. Apr 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

  4. Apr 2017 — Apr 2018 [monthly]

    Active Not Recruiting PHASE1

  5. Feb 2017 — Apr 2017 [monthly]

    Active Not Recruiting PHASE1

  6. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1

    First recorded

Sep 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Spark Therapeutics, Inc.
Data source: Spark Therapeutics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations