RST-001 Phase I/II Trial for Advanced Retinitis Pigmentosa

Advanced Retinitis Pigmentosa Clinical Trial

Official title:

Phase I/IIa, Open-Label, Dose-Escalation Study of Safety and Tolerability of Intravitreal RST-001 in Patients With Advanced Retinitis Pigmentosa (RP)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02556736
• Other study ID #: RST-001-CP-0001
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: December 14, 2015
• Est. completion date: September 23, 2024

Study information

• Verified date: November 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently enrolling a total of 12 patients for Phase 2a of the study: 6 patients must have VA of no-better-than hand motion in the study eye, and 6 patients must have VA in the study eye to range from no-worse-than count fingers to 20/200 vision.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: September 23, 2024
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

Participants must meet all of the following criteria.

1. Age >= 18 years

2. Signed and dated written informed consent obtained from the patient.

3. Ability to comply with testing and all protocol tests.

Exclusion criteria:

Any one of the following will exclude patients from being enrolled into the study:

1. Unable or unwilling to meet requirements of the study;

2. Participation in a clinical study (ocular or non-ocular) with an investigational drug, agent or therapy in the past six months

Related Conditions & MeSH terms

• Advanced Retinitis Pigmentosa
• Retinitis
• Retinitis Pigmentosa

Intervention

Drug:
• RST-001
RST-001 is a gene therapeutic delivered by intravitreal injection

Locations

Country	Name	City	State
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Retina Foundation of the Southwest	Dallas	Texas
United States	Duke Eye Center	Durham	North Carolina
United States	University of California, San Francisco- Dept. of Ophthalmology	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Any Grade 3 or Greater Adverse Event (AE) Considered Related to RST-001.	The U.S. Dept. of Health and Human Services' Common Terminology Criteria for Adverse Events grades AEs from 1 (Mild) to 5 (Death related to AE).; Grade 3 is defined as "Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Activities of Daily Living (ADL)	Baseline (Day 1) to 6 Months

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.