VP-001 for Retinal Dystrophy

(DINGO Trial)

Recruiting at5 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: PYC Therapeutics

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a repeat-dose, open-label, four arm safety and efficacy study of two doses of VP-001 administered intravitreally in participants with confirmed PRPF31 mutation-associated Retinal Dystrophy and previously treated with VP001.

Research Team

Eligibility Criteria

This trial is for individuals with PRPF31 mutation-associated Retinal Dystrophy who have already been treated with VP-001. Specific eye conditions like fungal retinitis, Purtscher retinopathy, and other related diseases are the focus. Participants must meet certain health standards to be included.

Inclusion Criteria

I have Retinitis Pigmentosa due to a PRPF31 gene mutation.

Understand the language of the informed consent and are willing and able to provide written informed consent prior to any study procedures

Are willing to comply with the instruction and attend all scheduled study visits

Exclusion Criteria

I have had eye surgery within the last 3 months.

Have a recent history (<6 months) or current excessive recreational drug or alcohol use, in the opinion of the investigator

I've had Ozurdex, Retisert, or Iluvien implants within the specified time frames.

Treatment Details

Interventions

• VP-001 (Virus Therapy)

Trial Overview The study tests two doses of a drug called VP-001, given as an injection inside the eye (intravitreally). It's designed to see how safe and effective these doses are in treating specific types of inherited eye disorders.

Participant Groups

Group I: Cohort 4: 75ug of VP-001 every 12 weeks Experimental Treatment 1 Intervention

treated with 75ug of VP-001, administered IVT, every 12 weeks

Group II: Cohort 3: 75ug of VP-001 every 8 weeks Experimental Treatment 1 Intervention

treated with 75ug of VP-001, administered IVT, every 8 weeks

Group III: Cohort 2: 120ug of VP-001 every 12 weeks Experimental Treatment 1 Intervention

treated with 120ug of VP-001, administered IVT, every 12 weeks

Group IV: Cohort 1: 120ug VP-001 every 8 weeks Experimental Treatment 1 Intervention

treated with 120ug of VP-001, administered IVT, every 8 weeks

Who Is Running the Clinical Trial?

PYC Therapeutics

Lead Sponsor

Trials

7

Recruited

170+