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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 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.

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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.

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

FieldValue
Enrollment Target 16 participants
Start Date 2025-06-01
Est. Completion 2028-03-03
Phase Phase 1

Sponsor

PYC Therapeutics

5 total trials

What the Registry Record Tells You About NCT06852963

The ClinicalTrials.gov registry entry for NCT06852963 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,240-participant average among 19 other Retinal Disease trials with a reported enrollment target (99% lower). The listed sponsor is PYC Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 4 distinct geographic areas - top geographies include 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.

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

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