Title
RST-001 Phase I/II Trial for Advanced Retinitis Pigmentosa
Phase I/IIa, Open-Label, Dose-Escalation Study of Safety and Tolerability of Intravitreal RST-001 in Patients With Advanced Retinitis Pigmentosa (RP)
Phase
Phase 1/Phase 2Lead Sponsor
RetroSense TherapeuticsStudy Type
InterventionalStatus
Active, not recruiting Results PostedIndication/Condition
Advanced Retinitis PigmentosaIntervention/Treatment
rst-001 ...Study Participants
14Currently 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.
RST-001 is a gene therapeutic delivered by intravitreal injection
Inclusion criteria: Participants must meet all of the following criteria. Age >= 18 years Signed and dated written informed consent obtained from the patient. 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: Unable or unwilling to meet requirements of the study; Participation in a clinical study (ocular or non-ocular) with an investigational drug, agent or therapy in the past six months
| Event Type | Organ System | Event Term | 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)
