A Phase I/II Dose-escalating Study of the Safety, Tolerability and Efficacy of KIO-301 Administer… (NCT05282953) | Clinical Trial Compass
CompletedPhase 1/2
A Phase I/II Dose-escalating Study of the Safety, Tolerability and Efficacy of KIO-301 Administered Intravitreally to Patients With Retinitis Pigmentosa and Choroideremia (ABACUS)
Australia32 participantsStarted 2022-11-10
Plain-language summary
A phase I/II dose-escalating study of the safety, tolerability and efficacy of KIO-301 administered intravitreally to patients with retinitis pigmentosa and choroideremia (ABACUS).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Be aged 18 to 80 years at Visit 1 of either sex and of any race.
✓. Be willing and able to provide informed consent either written, or if the Participant is not able to read, provide consent as stipulated by local laws and Human Research Ethics Committee (HREC) guidelines.
✓. Be willing and able to follow all instructions and attend all study visits.
✓. Have a clinical diagnosis of retinitis pigmentosa (Cohorts 1 - 3) or choroideremia (Cohort 3 only).
✓. Have a visual acuity of:
✓. no light perception for Cohort 3 or
✓. no light perception or bare light perception for Cohort 1 confirmed with a LogMar \> 2.9 using the Berkeley Rudimentary Vision Test (BRVT), or
✓. count fingers or hand motion for Cohort 2 as confirmed by a LogMar ≤ 2.9 and \> 1.6 using the BRVT.
Exclusion criteria
✕. Have evidence of material/substantial optic nerve disease.
✕. Have a history of retinal detachments.
✕. Have clinically significant ocular disease (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study or clinically significant opacities of the media.
✕. Have high intraocular pressure (IOP) \>22 mm Hg.
✕. Have had a previous intraocular surgery (excluding phakocataract surgery).
✕. Have aphakia.
✕. Have a psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to Screening, a history of suicide plan.
✕. Have any clinically significant abnormality at Screening determined by medical history, vital signs, blood chemistry, haematology, urinalysis or a 12-lead electrocardiogram (ECG), as assessed by the investigator.