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

AbbVie

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Retinitis Pigmentosa

Treatments: Drug: RST-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT02556736

RST-001-CP-0001

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

14 participants in 1 patient group

Group 1

Experimental group

Description:

Single intravitreal injection of RST-001

Treatment:

Drug: RST-001