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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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ClinicalTrials.gov Identifier: NCT05282953
Recruitment Status : Recruiting
First Posted : March 16, 2022
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Kiora Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Choroideremia Drug: KIO-301 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : November 10, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with Retinitis Pigmentosa and Choroideremia Drug: KIO-301
KIO-301 intravitreal injection at ascending doses


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 84 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05282953


Contacts
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Contact: Eric Daniels, M.D., MBA 61 448787315 edaniels@kiorapharma.com

Locations
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Australia, South Australia
Royal Adeliade Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Robert Casson         
Harley Eye Clinic Recruiting
North Adelaide, South Australia, Australia, 5006
Contact: Robert Casson    08 8267 6544      
Sponsors and Collaborators
Kiora Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Robert Casson Royal Adelaide Hospital
More Information
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Responsible Party: Kiora Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05282953    
Other Study ID Numbers: KIO-301-1101
First Posted: March 16, 2022    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Choroideremia
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
 Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Choroid Diseases
Uveal Diseases
Genetic Diseases, X-Linked