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NCT04483440 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of Intravitreal 4D-110 in Patients With Choroideremia
A Phase 1 study of Choroideremia, sponsored by 4D Molecular Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 2
- Study locations
NCT04483440: Active Phase 1 study of Choroideremia, sponsored by 4D Molecular Therapeutics.
NCT04483440 is a Phase 1 study of Choroideremia that is active but no longer recruiting, run by 4D Molecular Therapeutics. The registered enrollment target is 13 participants, below the 3,133-participant average among 7 other Choroideremia trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04483440, a Phase 1 study of Choroideremia, is active but no longer recruiting, sponsored by 4D Molecular Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will evaluate safety, tolerability, and preliminary efficacy of a single intravitreal (IVT) injection of a recombinant adeno-associated virus (AAV) gene therapy, 4D-110, in male patients with genetically-confirmed Choroideremia (CHM).
Primary Outcome
Frequency and severity of ocular and systemic AEs including clinically significant changes in ocular evaluations, systemic examinations and laboratory testing.
Conditions Studied
Interventions
- BIOLOGICAL 4D-110
Study Locations (2)
Texas
- Retina Foundation of the Southwest - Dallas
Utah
- Moran Eye Center, University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-06-02 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 1 |
What the registry record for NCT04483440 still lists
NCT04483440 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 3,133-participant average among 7 other Choroideremia trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Choroideremia appearing as the primary indexed condition, and to 1 intervention - of which 4D-110 is the first listed.
NCT04483440 reports a single indexed study location in Texas, Utah.
Frequently Asked Questions
What is clinical trial NCT04483440 about?
NCT04483440 is a clinical study titled "Dose Escalation Study of Intravitreal 4D-110 in Patients With Choroideremia". This study will evaluate safety, tolerability, and preliminary efficacy of a single intravitreal (IVT) injection of a recombinant adeno-associated virus (AAV) gene therapy, 4D-110, in male patients with genetically-confirmed Choroideremia (CHM).
What is the current status of trial NCT04483440?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2020-06-02. Estimated completion is 2027-08-31.
What conditions does trial NCT04483440 study?
This clinical trial studies the following conditions: Choroideremia.
What interventions are being tested in trial NCT04483440?
The interventions under investigation include: 4D-110 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04483440?
This trial is sponsored by 4D Molecular Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04483440 being conducted?
This trial has 2 study locations across Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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