12 Participants Needed

VP-001 for Retinal Dystrophy

Recruiting at 4 trial locations
OI
Overseen ByOra Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VP-001, a potential drug, to determine its safety and tolerability for individuals with retinal dystrophy linked to the PRPF31 gene mutation. Retinal dystrophy can cause vision problems, so the study aims to explore whether VP-001 can help manage these issues. The trial seeks participants diagnosed with PRPF31-related retinal dystrophy who have specific levels of vision impairment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have used anti-VEGF agents within 2 months or corticosteroid injections within the last 3 months. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that VP-001 is likely to be safe for humans?

Research has shown that VP-001 was well-tolerated in earlier studies. In one study, participants with a specific genetic condition received this treatment multiple times, and it proved to be safe. They did not experience any major side effects, indicating no serious or unexpected problems. This suggests that VP-001 is generally safe for humans based on existing data. However, since the current trial is in an early stage, the main goal is to further confirm its safety and assess how well people can tolerate it.12345

Why do researchers think this study treatment might be promising?

VP-001 is unique because it offers a novel approach to treating retinal dystrophy. Unlike existing treatments, which often focus on managing symptoms with vitamins or surgery, VP-001 targets the underlying causes of the condition at a molecular level. Researchers are excited about VP-001 because it uses a new mechanism of action that could potentially stop or even reverse the progression of retinal dystrophy. This innovative approach provides hope for more effective and long-lasting results compared to current therapies.

What evidence suggests that VP-001 might be an effective treatment for retinal dystrophy?

Research has shown that VP-001, the investigational treatment in this trial, offers promising results for treating retinal dystrophy caused by the PRPF31 mutation. Studies have found that VP-001 can enhance visual clarity. In one study, participants achieved better vision scores, improving from seeing at 20/47 to a clearer level. The treatment also appears to slow the loss of cells in the eye that are crucial for vision. Overall, these findings suggest that VP-001 may effectively aid individuals with this specific type of retinal dystrophy.23467

Are You a Good Fit for This Trial?

This trial is for individuals with confirmed PRPF31 mutation-associated retinal dystrophy, a genetic disorder causing vision loss. Details on specific inclusion and exclusion criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I am at least 12 years old.
I have a PRPF31 genetic mutation.
Understand the language of the informed consent and provide written informed consent
See 4 more

Exclusion Criteria

Recent excessive recreational drug or alcohol use
I do not have any uncontrolled illnesses that would stop me from joining the study.
Recent use of investigational drugs or devices
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending doses of intravitreally administered VP-001

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • VP-001
Trial Overview The trial is testing multiple increasing doses of VP-001 given through an injection into the eye (intravitreally) to assess its safety and how well it's tolerated in patients with retinal dystrophy due to PRPF31 mutations.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Multi-ascending dose escalation study of VP-001Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

PYC Therapeutics

Lead Sponsor

Trials
7
Recruited
170+

Citations

NCT06852963 | A Study of Two Doses of VP-001 ...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 ...
A Study of Two Doses of VP-001 Administered Intravitreally in ...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 ...
A Study of Two Doses of VP-001 Administered Intravitreally in ...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 ...
VP-001 for Retinal Dystrophy (DINGO Trial)The treatment also led to a significant improvement in visual acuity, with an average decrease in logMAR scores indicating a change from approximately 20/47 to ...
Nacuity Pharmaceuticals Announces Positive Data from ...NPI-001 shows more than 50% reduction in photoreceptor loss caused by RP associated with USH over two years. NPI-001 was well tolerated, ...
NCT06455826 | MAD of IVT VP-001 in PRPF31 Mutation- ...A Phase 1 Open-Label, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of Intravitreally Administered VP-001 in Participants with ...
VP-001 as an interventional therapy for patients with ...In vitro studies were performed on 45-day old ROS after a single treatment of VP-001, followed by half media changes every 2-3 days for 28 days. PRPF31 protein ...
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