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NCT06852963 · ClinicalTrials.gov registry record · Phase 1
A Repeat-Dose, Open-Label, Two Arm Safety and Efficacy Study of Two Doses of VP-001 Administered Intravitreally in Participants With Confirmed PRPF31 Mutation-Associated Retinal Dystrophy, Including Participants Previously Treated With VP001
A Phase 1 study of Retinal Disease and Retinal Degeneration, sponsored by PYC Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 6
- Study locations
NCT06852963: Recruiting Phase 1 study of Retinal Disease and Retinal Degeneration, sponsored by PYC Therapeutics.
NCT06852963 is a Phase 1 study of Retinal Disease and Retinal Degeneration that is actively recruiting participants, run by PYC Therapeutics. The registered enrollment target is 16 participants, below the 1,240-participant average among 19 other Retinal Disease trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06852963, a Phase 1 study of Retinal Disease and Retinal Degeneration, is actively recruiting participants, sponsored by PYC Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a Phase 1/2 repeat-dose, open-label, two-arm, parallel group safety and efficacy study of two doses of VP-001 (30 μg and 75 μg) in participants with confirmed PRPF31 mutation-associated retinal dystrophy, including participants previously treated with VP001 in the PLATYPUS Study or WALLABY Study for a minimum of 8 weeks.
Primary Outcome
The incidence, severity, and relatedness of ocular TEAEs and TE-SAEs in the study eye over a 26-month time period for each of the repeat doses
Conditions Studied
Interventions
- DRUG VP-001
Study Locations (6)
Florida
- University of Florida College of Medicine - Jacksonville
- Bascom Palmer Eye Institute - University of Miami - Miami
Texas
- Retina Foundation of the Southwest - Dallas
- Baylor College of Medicine - Houston
Michigan
- Kellogg Eye Center - University of Michigan - Ann Arbor
Oregon
- Casey Eye Institute - OHSU - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2025-06-01 |
| Est. Completion | 2028-03-03 |
| Phase | Phase 1 |
What NCT06852963 shows while recruiting
NCT06852963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,240-participant average among 19 other Retinal Disease trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Retinal Disease appearing as the primary indexed condition, and to 1 intervention - of which VP-001 is the first listed.
NCT06852963 lists 6 locations in 4 states (Florida, Texas, Michigan).
Frequently Asked Questions
What is clinical trial NCT06852963 about?
NCT06852963 is a clinical study titled "A Repeat-Dose, Open-Label, Two Arm Safety and Efficacy Study of Two Doses of VP-001 Administered Intravitreally in Participants With Confirmed PRPF31 Mutation-Associated Retinal Dystrophy, Including Participants Previously Treated With VP001". This is a Phase 1/2 repeat-dose, open-label, two-arm, parallel group safety and efficacy study of two doses of VP-001 (30 μg and 75 μg) in participants with confirmed PRPF31 mutation-associated retinal dystrophy, including participants previously treated with VP001 in the PLATYPUS Study or WALLABY S...
What is the current status of trial NCT06852963?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2025-06-01. Estimated completion is 2028-03-03.
What conditions does trial NCT06852963 study?
This clinical trial studies the following conditions: Retinal Disease, Retinal Degeneration, Eye Diseases, Hereditary, Retinal Dystrophies, Retinitis Pigmentosa 11.
What interventions are being tested in trial NCT06852963?
The interventions under investigation include: VP-001 (DRUG).
Who is sponsoring clinical trial NCT06852963?
This trial is sponsored by PYC Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06852963 being conducted?
This trial has 6 study locations across Florida, Michigan, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06852963's enrollment target sits among peer trials
16 18th of 19 higher than 2 of 19 other Retinal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Retinal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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