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New treatment option for Retinitis Pigmentosa
Official title A Phase II Study of Intravitreal KIO-301 in Patients With Late-stage Retinitis Pigmentosa
ClinicalTrials.gov ID: NCT06628947
What this study is testing
What is 100 μg KIO-301?
100 μg KIO-301 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for retinitis pigmentosa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- 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...
- 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...
See the full eligibility 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:
- 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.
- 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...
- Must agree to follow appropriate contraception requirements from Screening until 3 months after the last dose of IMP.
- Participants assigned female at birth who are of child-bearing potential (OCBP) must agree to a pregnancy test at Screening and use an acceptable method of birth control including oral, transdermal, injectable, or...
- Participants assigned male at birth with a partner OCBP must be surgically sterile for at least 3 months prior to starting study drug, or ensure their partner uses contraception as outlined above, and must use a male...
- Participants who have practiced true abstinence for at least 1 year due to usual and preferred lifestyle choice are exempt from contraceptive requirements. If a participant who is abstinent becomes sexually active, they...
- 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...
- 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.
- Have a psychiatric condition that, in the investigator's opinion, precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years...
- Have any clinically significant abnormality at screening determined by medical history, vital signs, clinical biochemistry, haematology, urinalysis, or a 12-lead electrocardiogram (ECG), as assessed by the investigator...
- Have any other medical condition or significant co-morbidities, or any finding during screening, which in the view of the Investigator is likely to interfere with the study or put the Participant at risk, confound study...
- Have clinical signs of active ocular or systemic infection and/or a temperature greater than 38.0°C at the time of screening. Study entry must be deferred at least 14 days from resolution.
- Have participated in any investigational study within 30 days prior to screening, prior exposure to an investigational product within 5 elimination half-lives, or planned used of an investigational product or device...
- Have known or suspected hypersensitivity to any of the study drug excipients.
- Are taking any medications that are known to be toxic to the retina or optic nerve.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- East Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Woolloongabba, Queensland, Australia; Adelaide, South Australia, Australia; East Melbourne, Victoria, Australia; Nedlands, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.