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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05282953
Registration number
NCT05282953
Ethics application status
Date submitted
8/03/2022
Date registered
16/03/2022
Date last updated
15/03/2024
Titles & IDs
Public title
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)
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Scientific title
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)
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Secondary ID [1]
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KIO-301-1101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Retinitis Pigmentosa
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Choroideremia
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - KIO-301
Experimental: Patients with Retinitis Pigmentosa and Choroideremia -
Treatment: Drugs: KIO-301
KIO-301 intravitreal injection at ascending doses
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with treatment-related adverse events as assessed by overall changes in retinal thickness and appearance, clinical chemistry and hematology, and other eye assessments.
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Assessment method [1]
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Timepoint [1]
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84 days
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Eligibility
Key inclusion criteria
1. Have a clinical diagnosis of retinitis pigmentosa (Cohorts 1 - 3) or choroideremia
(Cohort 3 only).
2. Have a visual acuity of:
1. no light perception for Cohort 3 or
2. no light perception or bare light perception for Cohort 1 confirmed with a LogMar
>2.9 using the Berkeley Rudimentary Vision Test (BRVT), or
3. count fingers or hand motion for Cohort 2 as confirmed by a LogMar = 2.9 and >
1.6 using the BRVT.
3. Have similar visual acuity in both eyes as defined as a LogMar difference between eyes
of < 0.05 using the BRVT.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Have evidence of material/substantial optic nerve disease.
2. Have a history of retinal detachments.
3. 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.
4. Have high intraocular pressure (IOP) >22 mm Hg.
5. Have had a previous intraocular surgery (excluding phakocataract surgery).
6. Have aphakia.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/11/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2025
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Actual
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Royal Adeliade Hospital - Adelaide
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Recruitment hospital [2]
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Harley Eye Clinic - North Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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5006 - North Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Kiora Pharmaceuticals, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
Open label.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05282953
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Robert Casson
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Address
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Royal Adelaide Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Eric Daniels, M.D., MBA
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Address
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Country
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Phone
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61 448787315
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05282953
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