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NCT07439887 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease
A Phase 1 study of Stargardt Disease, sponsored by Ray Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT07439887: Recruiting Phase 1 study of Stargardt Disease, sponsored by Ray Therapeutics.
NCT07439887 is a Phase 1 study of Stargardt Disease that is actively recruiting participants, run by Ray Therapeutics. The registered enrollment target is 18 participants, below the 90-participant average among 16 other Stargardt Disease trials with a reported enrollment target (80% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07439887, a Phase 1 study of Stargardt Disease, is actively recruiting participants, sponsored by Ray Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
A Phase 1/2, open-label, non-randomized, dose-escalation study, where a minimum of 9 and a maximum of 18 eligible patients with Stargardt Disease will be enrolled sequentially in up to 3 dose cohorts of RTx-021. Enrolled patients will receive a single, unilateral intravitreal injection of RTx-021 in the study eye and be followed for 5 years.
Primary Outcome
The number of patients in each cohort with treatment-emergent adverse events categorized using MedDRA v24.0 or higher
Conditions Studied
Interventions
- GENETIC RTx-021
Study Locations (2)
California
- RayTx Clinical Site - Bakersfield
Texas
- RayTx Clinical Site - Bellaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2026-01-28 |
| Est. Completion | 2030-12-01 |
| Phase | Phase 1 |
What NCT07439887 shows while recruiting
NCT07439887 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 90-participant average among 16 other Stargardt Disease trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Stargardt Disease appearing as the primary indexed condition, and to 1 intervention - of which RTx-021 is the first listed.
NCT07439887 reports a single indexed study location in California, Texas.
Frequently Asked Questions
What is clinical trial NCT07439887 about?
NCT07439887 is a clinical study titled "Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease". A Phase 1/2, open-label, non-randomized, dose-escalation study, where a minimum of 9 and a maximum of 18 eligible patients with Stargardt Disease will be enrolled sequentially in up to 3 dose cohorts of RTx-021. Enrolled patients will receive a single, unilateral intravitreal injection of RTx-021 in...
What is the current status of trial NCT07439887?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2026-01-28. Estimated completion is 2030-12-01.
What conditions does trial NCT07439887 study?
This clinical trial studies the following conditions: Stargardt Disease.
What interventions are being tested in trial NCT07439887?
The interventions under investigation include: RTx-021 (GENETIC).
Who is sponsoring clinical trial NCT07439887?
This trial is sponsored by Ray Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07439887 being conducted?
This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07439887's enrollment target sits among peer trials
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