A Phase II Study of Intravitreal KIO-301 in Patients With Late-stage Retinitis Pigmentosa
Trial Parameters
Brief Summary
The goal of the study is to investigate the safety, tolerability and efficacy of up to 3 doses of KIO-301 administered by intravitreal (IVT) injection bilaterally every 6 weeks in patients with late-stage retinitis pigmentosa (RP). Late-stage RP patients will include those patients with No Light Perception (NLP), or Low Vision (LV).
Eligibility Criteria
Inclusion Criteria: 1. Be aged 18 years or older at the time of consent. 2. Provide informed consent prior to any study procedures, as stipulated by local laws, Ethics Committee (EC) and Regulatory Authority (RA) guidelines. 3. Be willing and able to follow all study instructions, attend all study visits, and complete all study assessments. 4. Have a clinical diagnosis of non-syndromic RP, with the exception of Usher's Syndrome Type II (USH2) which is allowed. 5. Have a visual acuity as per the Berkeley Rudimentary Vision Test (BRVT) at Screening of: * NLP OU confirmed by inability to see pen torch light at 25 cm OD, OS, and OU (assigned logMAR of 4.0). * LV OU limited to logMAR \> 1.6 and \< 4.0. 6. Other than intravitreal corticosteroids, participants must not receive intravitreal concomitant medications from Screening until end of study. 7. For Low Vision (LV) OU participants only: must pass at least one multi-luminance functional vision (MLFV) test at two successive light levels (b