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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)

Primary Purpose

Retinitis Pigmentosa, Choroideremia

Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
KIO-301
Sponsored by
Kiora Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a clinical diagnosis of retinitis pigmentosa.
  • Have a visual acuity of no light perception or bare light perception for Cohort 1 confirmed with a LogMar >3 using the Berkeley Rudimentary Vision Test (BRVT), and have a visual acuity of count fingers or hand motion as confirmed by a LogMar < 3.0 and > 1.6 using the BRVT for Cohort 2.
  • 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.

Sites / Locations

  • Royal Adeliade HospitalRecruiting
  • Harley Eye ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Retinitis Pigmentosa and Choroideremia

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2022
Last Updated
October 3, 2023
Sponsor
Kiora Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05282953
Brief 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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kiora Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa, Choroideremia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with Retinitis Pigmentosa and Choroideremia
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KIO-301
Intervention Description
KIO-301 intravitreal injection at ascending doses
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Have similar visual acuity in both eyes as defined as a LogMar difference between eyes of < 0.05 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Daniels, M.D., MBA
Phone
61 448787315
Email
edaniels@kiorapharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Casson
Organizational Affiliation
Royal Adelaide Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adeliade Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Casson
Facility Name
Harley Eye Clinic
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Casson
Phone
08 8267 6544

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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