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Central Retinal Artery OcclusionPhase 2GIONNCT06178055

A Study of the Efficacy and Safety of KUS121 in Participants With Acute Non-Arteritic Central Retinal Artery Occlusion (CRAO)

A Phase 2 study testing KUS121 high dose and KUS121 low dose in people with Central Retinal Artery Occlusion, run by Kyoto Drug Discovery and Development Co., Ltd. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Central Retinal Artery Occlusion
What is being tested?
KUS121 high dose and KUS121 low dose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
11 sitesUnited States
Study dates
16 Apr 2024to 30 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Presence of the following conditions in the study eye:
  • Infection in or around the eye
  • Uncontrolled intraocular pressure
  • Abnormality in macula other than CRAO findings
  • History of macular photocoagulation
  • Opacity in visual axis preventing fundus examination or fundus imaging (e.g., corneal dystrophy)
Show all 20Show fewer
  • Neovascularization of iris and retina
  • Any inflammatory disease involving the eye
  • Optic atrophy
  • Glaucomatous cupping greater than 0.9
  • Prior vitrectomy
  • Aphakia with the absence of posterior capsule
  • Any IVT injection or sub-Tenon's injection within 1 month of screening
  • Any intraocular surgery or ocular implant within 3 months of screening
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Austin Retina Associates

    Austin, Texas, 78705

  • UH Eye Institute

    Cleveland, Ohio, 44106

  • Kresge Eye Institute/Wayne State University

    Detroit, Michigan, 48201

  • The Retina Partners

    Encino, California, 91436

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Salehi Retina Institute, Inc

    Huntington Beach, California, 92647

  • Florida Retina Institute

    Jacksonville, Florida, 32216

  • NYEE Infirmary of Mount Sinai

    New York, New York, 10003

  • Kaiser Permanente Oakland Med Ctr.

    Oakland, California, 94611

  • Retina Consultants of Texas

    San Antonio, Texas, 78240

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

Other trials in United States

About this study

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)

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.

Read the detailed description

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.

Being tested
KUS121 high dose, KUS121 low dose, Sham procedure
Medical subject headings
Retinal Artery Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KUS121 high doseDrug

    Participants will receive KUS121 high dose intravitreal (IVT) injection once on each of 3 consecutive days (Day 1 through Day 3).

  • KUS121 low doseDrug

    Participants will receive KUS121 low dose intravitreal (IVT) injection once on each of 3 consecutive days (Day 1 through Day 3).

  • Sham procedureDrug

    Participants will receive a sham procedure that mimics an intravitreal (IVT) injection once on each of 3 consecutive days (Day 1 through Day 3).

Study groups in NCT06178055
Study groupRoleWhat they receive
KUS121 high dose groupExperimentalNot described
Receives: Drug: KUS121 high dose
KUS121 low dose groupExperimentalNot described
Receives: Drug: KUS121 low dose
Control groupSham comparatorNot described
Receives: Drug: Sham procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of study eyes which achieve a gain of 15 ETDRS letters or more in BCVA at Week 12 compared to baseline

    BCVA: Best-Corrected Visual Acuity; ETDRS: Early Treatment Diabetic Retinopathy Study. A higher ETDRS letter score means a better outcome (better visual acuity).

    Measured: At baseline, Week 12

Secondary outcomes (8)

  1. Proportion of study eyes which achieve a gain of 15 ETDRS letters or more in BCVA at Week 4 compared to baseline

    Measured: At baseline, Week 4

  2. Proportion of study eyes which achieve a gain of 0.3 Logarithm of Minimum Angle of Resolution (Log MAR) in BCVA at Week 12 compared to baseline

    BCVA will be recorded using a Logarithm of the Minimum Angle of Resolution (LogMAR) scoring chart. A lower LogMAR score means a better outcome (better visual acuity).

    Measured: At baseline, Week 12

  3. Proportion of study eyes which achieve a gain of 10 ETDRS letters or more in BCVA at Week 12 compared to baseline

    Measured: At baseline, Week 12

  4. Mean change in BCVA (readable letters and Log MAR) at Week 12 compared to baseline

    Measured: At baseline, Week 12

  5. Change in retinal thickness from baseline at Week 12 as measured by SD-OCT

    Measured: At baseline, Week 12

  6. Change in the area of visual field from baseline to Week 12 as measured by Humphrey Field Analyzer

    The Humphrey Visual Field Analyser test assesses the retina's ability to detect a light stimulus at specific points within the visual field. A higher score means a better outcome (better visual field).

    Measured: At baseline, Week 12

  7. Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)

    Measured: From baseline through Week 48

  8. Patients Reported Outcome

    The results of National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) for each group at before, afterwards the disease onset and Week 12. A higher score means a better functioning (better patient-reported visual function).

    Measured: Up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2023
  2. Study start16 Apr 2024
  3. Primary completion3 Mar 2025
  4. Study completion30 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06178055
Sponsor's protocol ID
KDK-1101-02
Acronym
GION
Status last verified
Feb 2026
First submitted
1 Dec 2023
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ikeda HO, Muraoka Y, Hata M, Sumi E, Ikeda T, Nakagawa T, Abe H, Tada H, Morita S, Kakizuka A, Yoshimura N, Tsujikawa A. Safety and effectiveness of a novel neuroprotectant, KUS121, in patients with non-arteritic central retinal artery occlusion: An open-label, non-randomized, first-in-humans, phase 1/2 trial. PLoS One. 2020 Feb 13;15(2):e0229068. doi: 10.1371/journal.pone.0229068. eCollection 2020.

    PubMed 32053676

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KUS121 high dose and KUS121 low dose in people with Central Retinal Artery Occlusion, run by Kyoto Drug Discovery and Development Co., Ltd. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of study eyes which achieve a gain of 15 ETDRS letters or more in BCVA at Week 12 compared to baseline (time frame: At baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06178055, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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