A Phase II Study of Intravitreal KIO-301 in Patients With Late-stage Retinitis Pigmentosa (NCT06628947) | Clinical Trial Compass
RecruitingPhase 2
A Phase II Study of Intravitreal KIO-301 in Patients With Late-stage Retinitis Pigmentosa
Australia36 participantsStarted 2025-08-29
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be aged 18 years or older at the time of consent.
✓. Provide informed consent prior to any study procedures, as stipulated by local laws, Ethics Committee (EC) and Regulatory Authority (RA) guidelines.
✓. Be willing and able to follow all study instructions, attend all study visits, and complete all study assessments.
✓. Have a clinical diagnosis of non-syndromic RP, with the exception of Usher's Syndrome Type II (USH2) which is allowed.
✓. Have a visual acuity as per the Berkeley Rudimentary Vision Test (BRVT) at Screening of:
✓. Other than intravitreal corticosteroids, participants must not receive intravitreal concomitant medications from Screening until end of study.
✓. For Low Vision (LV) OU participants only: must pass at least one multi-luminance functional vision (MLFV) test at two successive light levels (between 1 and 500 lux), or at 1400 lux. Additionally, they must fail the same test at 0.125 and 0.35 lux.
✓. Must agree to follow appropriate contraception requirements from Screening until 3 months after the last dose of IMP.
Exclusion criteria
✕. Pregnant or breast-feeding, or plan to become pregnant during the study.
✕. Have, in the investigator's opinion, evidence of material/substantial optic nerve disease.
✕. Have a history of one or more retinal detachments.
What they're measuring
1
To assess the safety and tolerability of multiple doses of KIO-301 administered by IVT injection bilaterally of KIO-301 in patients with late-stage RP.
Timeframe: Baseline (Week 1/pre-dose) to Week 25 (12 weeks post 3rd IVT administration of KIO-301)
✕. Other than RP related macular pathologies, have in the investigator's opinion, clinically significant ocular disease (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca), or clinically significant opacities of the media which might interfere with the study assessments, or the ability of the participant to complete the study.
✕. Have a history of high myopia (\> 6 diopters).
✕. Have uncontrolled severe glaucoma defined as intraocular pressure (IOP) of \> 26 mmHg when on 2 or more IOP lowering medications and cup disc ratio of ≥ 0.8, as diagnosed by an ophthalmologist.
✕. Have had a previous intraocular surgery (with the exception of phacoemulsification cataract surgery and YAG capsulotomy more than 12 months prior to first study drug administration, which is allowed).
✕. Have aphakia or a subluxed intraocular lens, or have evidence of zonular weakness that in the opinion of the investigator would result in light obfuscation.