A Phase II Study of Intravitreal KIO-301 in Patients With Late-stage Retinitis Pigmentosa
ConditionRetinitis Pigmentosa
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKiora Pharmaceuticals, Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- Placebo (Sterile Saline or Balanced Salt Solution)
- 100 μg KIO-301
- 50 μg KIO-301
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov