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NCT03920007 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Leber Congenital Amaurosis and LCA, sponsored by Atsena Therapeutics.

Active
Registry status
Phase 1
Development phase
15
Enrollment target
2
Study locations

NCT03920007 is a Phase 1 study of Leber Congenital Amaurosis and LCA that is active but no longer recruiting, run by Atsena Therapeutics. The registered enrollment target is 15 participants, below the 26-participant average among 6 other Leber Congenital Amaurosis trials with a reported enrollment target (42% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03920007, a Phase 1 study of Leber Congenital Amaurosis and LCA, is active but no longer recruiting, sponsored by Atsena Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
15 participants
Enrollment target
2
Study locations

Study Summary

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.

Conditions Studied

Leber Congenital Amaurosis LCA LCA1

Interventions

  • DRUG Prednisone
  • DRUG ATSN-101
  • DRUG ATSN-101 Diluent Solution
  • DRUG Triamcinalone Acetonide
  • DRUG 1% Prednisolone

Study Locations (2)

Oregon

  • Casey Eye Institute - Oregon Health & Science University - Portland

Pennsylvania

  • Scheie Eye Institute, University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2019-09-12
Est. Completion 2027-05-19
Phase Phase 1

Sponsor

Atsena Therapeutics

2 total trials

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What the Registry Record Tells You About NCT03920007

The ClinicalTrials.gov registry entry for NCT03920007 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26-participant average among 6 other Leber Congenital Amaurosis trials with a reported enrollment target (42% lower). The listed sponsor is Atsena Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Leber Congenital Amaurosis appearing as the primary indexed condition, and to 5 interventions - of which Prednisone is the first listed.

NCT03920007 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Oregon, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03920007 about?

NCT03920007 is a clinical study titled "Study of Subretinally Injected ATSN-101 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D". 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...

What is the current status of trial NCT03920007?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-09-12. Estimated completion is 2027-05-19.

What conditions does trial NCT03920007 study?

This clinical trial studies the following conditions: Leber Congenital Amaurosis, LCA, LCA1.

What interventions are being tested in trial NCT03920007?

The interventions under investigation include: Prednisone (DRUG), ATSN-101 (DRUG), ATSN-101 Diluent Solution (DRUG), Triamcinalone Acetonide (DRUG), 1% Prednisolone (DRUG).

Who is sponsoring clinical trial NCT03920007?

This trial is sponsored by Atsena Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03920007 being conducted?

This trial has 2 study locations across Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.