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Gene Therapy

RST-001 for Retinitis Pigmentosa

Phase 1 & 2

Waitlist Available

Research Sponsored by Allergan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age must be greater than or equal to 18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 months

Awards & highlights

Study Summary

This trial is testing an experimental treatment for macular degeneration. It is enrolling 12 patients total, 6 of which must have very poor vision in the study eye, and 6 of which must have vision ranging from poor to 20/200.

Who is the study for?

This trial is for adults over 18 with advanced retinitis pigmentosa. Participants must be able to follow the study's procedures and have given written consent. Those with very limited vision (no better than hand motion) or moderately limited vision (up to 20/200) can join. People who've been in another drug study within the last six months cannot participate.Check my eligibility

What is being tested?

The trial is testing RST-001, a new potential treatment for retinitis pigmentosa. It involves a small group of just 12 patients in Phase I/II to assess how well it works and its safety at different stages of visual impairment.See study design

What are the potential side effects?

Since this summary does not provide specific side effects of RST-001, we can assume that as an investigational therapy for a condition affecting the eyes, potential side effects may include eye irritation, discomfort, or changes in vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Any Grade 3 or Greater Adverse Event (AE) Considered Related to RST-001.

Secondary outcome measures

Change in Ambulation

Change in Quality of Life

Visual Acuity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Group 1Experimental Treatment1 Intervention

Single intravitreal injection of RST-001

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor

781 Previous Clinical Trials

276,555 Total Patients Enrolled

1 Trials studying Retinitis Pigmentosa

21 Patients Enrolled for Retinitis Pigmentosa

AbbVieLead Sponsor

954 Previous Clinical Trials

501,030 Total Patients Enrolled

Hanh Badger, PharmDStudy DirectorAllergan

1 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

RST-001 (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02556736 — Phase 1 & 2

Retinitis Pigmentosa Research Study Groups: Group 1

Retinitis Pigmentosa Clinical Trial 2023: RST-001 Highlights & Side Effects. Trial Name: NCT02556736 — Phase 1 & 2

RST-001 (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02556736 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous facilities administering the experiment within this state?

"At present, 4 medical centres are recruiting for this trial. Dallas, San Francisco and Cincinnati have established locations where patients can participate in the study while other cities house additional potential sites of enrolment. To reduce travelling burdens it is recommended to choose the closest location available when enrolling."

Answered by AI

Is the recruitment process for this clinical trial currently underway?

"Clinicaltrials.gov shows that this research project is no longer accepting participants, as the last update to its posting was made on September 9th 2022. Despite this trial being inactive, there are 51 other trials actively recruiting patients at present time."

Answered by AI