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)

Last updated: March 4, 2025
Sponsor: Kiora Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Eye Disorders/infections

Retinitis Pigmentosa

Posterior Uveitis

Treatment

KIO-301

Clinical Study ID

NCT05282953
KIO-301-1101
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Have a clinical diagnosis of retinitis pigmentosa (Cohorts 1 - 3) or choroideremia (Cohort 3 only).

  2. Have a visual acuity of:

  3. no light perception for Cohort 3 or

  4. no light perception or bare light perception for Cohort 1 confirmed with aLogMar >2.9 using the Berkeley Rudimentary Vision Test (BRVT), or

  5. count fingers or hand motion for Cohort 2 as confirmed by a LogMar ≤ 2.9 and > 1.6 using the BRVT.

  6. Have similar visual acuity in both eyes as defined as a LogMar difference betweeneyes of < 0.05 using the BRVT.

Exclusion

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, severekeratoconjunctivitis sicca) which might interfere with the study or clinicallysignificant 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.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: KIO-301
Phase: 1/2
Study Start date:
November 10, 2022
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Royal Adeliade Hospital

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Harley Eye Clinic

    North Adelaide, South Australia 5006
    Australia

    Active - Recruiting

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