Summary

Eligibility
for people ages 20 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Christopher Toomey, MD, PhD (ucsd)

Description

Summary

Central retinal artery occlusion (CRAO) is an ophthalmologic emergency which leads to severe and permanent vision loss. There is no evidence-based therapy for CRAO. The objective of this GION study is to evaluate the efficacy and safety of KUS121 intravitreal (IVT) injection in participants with acute non-arteritic CRAO.

Official Title

A Phase 2, Double-masked, Randomized, Sham-controlled, Multiple-dose Study of the Efficacy and Safety of Intravitreal KUS121 in the Treatment of Non-Arteritic Central Retinal Artery Occlusion (CRAO)

Details

This is a Phase II, double-masked, sham-controlled, multi-center, parallel-group study to evaluate the efficacy and safety of KUS121 intravitreal (IVT) injection in patients with non-arteritic Central Retinal Artery Occlusion (CRAO) diagnosed and treated within 3-48 hours of disease onset. Participants will be randomized to high dose KUS121, low dose KUS121, or sham in a 1:1:1 ratio. Participants will receive daily intravitreal injections of KUS 121 or sham, which mimics an injection, from Day 1 through Day 3. Primary efficacy endpoint is the proportion of participants who gain 15 letters or more in BCVA compared with baseline and will be assessed at Week 12. Safety evaluation will continue until a 12-month follow up.

Keywords

Central Retinal Artery Occlusion, Retinal Artery Occlusion, Arterial Occlusive Diseases, KUS121 high dose, KUS121 low dose

Eligibility

You can join if…

Open to people ages 20 years and up

  • Participants who are willing and able to comply with clinic visits and study-related procedures and able to provide signed informed consent in person or from their legally authorized representative
  • Males and females ≥ 20 years of age at that time of providing signed informed consent
  • Diagnosed as non-arteritic Central Retinal Artery Occlusion from 3 hours until no more than 48 hours after the onset of significant visual acuity changes
  • Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 0 to 35 in the study eye at screening prior to enrollment (eyes with 'no light perception' or 'light perception' are to be excluded)
  • Retinal thickening or hyper-reflectivity in retinal inner layers in spectral domain optical coherence tomography (SD-OCT), or white turbid edema in fundus examination

You CAN'T join if...

  • Presence of the following conditions in the study eye:
    1. Infection in or around the eye
    2. Uncontrolled intraocular pressure
    3. Abnormality in macula other than CRAO findings
    4. History of macular photocoagulation
    5. Opacity in visual axis preventing fundus examination or fundus imaging (e.g., corneal dystrophy)
    6. Neovascularization of iris and retina
    7. Any inflammatory disease involving the eye
    8. Optic atrophy
    9. Glaucomatous cupping greater than 0.9
    10. Prior vitrectomy
    11. Aphakia with the absence of posterior capsule
    12. Any IVT injection or sub-Tenon's injection within 1 month of screening
    13. Any intraocular surgery or ocular implant within 3 months of screening
    14. Any history of ocular trauma within 3 months of screening
  • Thrombolytic, fibrinolytic or prostaglandin E1 systemic treatment within 1 month of screening
  • A positive urine pregnancy test on Day 1 prior to study enrollment
  • History of allergy or hypersensitivity to KUS121 or a compound with a condensed polycyclic aromatic hydrocarbon skeleton represented by naphthalene and any of excipients of KUS121 product, fluorescein, or any study treatment-related mandatory ingredients that is not amenable to treatment
  • Known hypersensitivity to a study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study
  • Presence of other medical disease, physical or ocular examination finding, or clinical laboratory finding that in the opinion of the Investigator contraindicates the use of an investigational product, might interfere with the evaluation of the efficacy or safety of the study drug, may put the participant at significant risk or might interfere with the participant's ability to participate in the study

Locations

  • Jacobs Retina Center, UCSD accepting new patients
    La Jolla California 92037 United States
  • The Retina Partners accepting new patients
    Encino California 91436 United States
  • Atlantis Eyecare accepting new patients
    Huntington Beach California 92647 United States
  • Salehi Retina Institute, Inc accepting new patients
    Huntington Beach California 92647 United States
  • Kaiser Permanente Oakland Med Ctr. accepting new patients
    Oakland California 94611 United States
  • Retina Consultants of Orange County accepting new patients
    Fullerton California 92835 United States
  • California Eye Specialists Medical Group, Inc. accepting new patients
    Pasadena California 91107 United States

Lead Scientist at University of California Health

  • Christopher Toomey, MD, PhD (ucsd)
    Assistant Professor Of Clinical, Ophthalmology, Vc-health Sciences-schools. Authored (or co-authored) 28 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kyoto Drug Discovery and Development Co., Ltd.
ID
NCT06178055
Phase
Phase 2 Central Retinal Artery Occlusion Research Study
Study Type
Interventional
Participants
Expecting 75 study participants
Last Updated