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KUS121 low dose group for Central Retinal Artery Occlusion (GION Trial)

Phase 2

Recruiting

Research Sponsored by Kyoto Drug Discovery and Development Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline through week 48

Awards & highlights

GION Trial Summary

"This trial is investigating the effectiveness and safety of KUS121 injection in patients with a sudden vision loss condition called central retinal artery occlusion, for which there is currently no proven treatment."

Who is the study for?

This trial is for men and women over 20 who've had a non-arteritic central retinal artery occlusion (CRAO) within the last 48 hours, with specific inflammation markers within normal ranges. They must have severe vision loss but not complete blindness in one eye and be able to attend clinic visits.Check my eligibility

What is being tested?

The study tests two doses of KUS121 via an eye injection against a sham procedure to see if it can help with acute CRAO, which currently has no proven treatment. The goal is to find out if this drug can improve vision safely.See study design

What are the potential side effects?

While the side effects are not detailed here, intravitreal injections like those used for KUS121 typically carry risks such as eye pain or irritation, increased pressure inside the eye, bleeding, or infection.

GION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline through week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline through week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

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

+5 more

GION Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: KUS121 low dose groupExperimental Treatment1 Intervention

Group II: KUS121 high dose groupExperimental Treatment1 Intervention

Group III: Control groupPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kyoto Drug Discovery and Development Co., Ltd.Lead Sponsor

Kunihiro Musashi, MD., Ph.D.Study ChairKyoto Drug Discovery ＆ Development Co., Ltd.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants enrolled in this medical study?

"Indeed, clinicaltrials.gov indicates that this study is presently seeking volunteers. This trial was initially posted on the 1st of April 2024 and last revised on the same day. Enrollment aims to recruit a total of 75 participants distributed among four distinct locations."

Answered by AI

What is the safety profile of the low-dose group receiving KUS121 in individuals?

"Our assessment at Power suggests that the safety rating for the low-dose group of KUS121 is a 2 on our scale. This score aligns with being in Phase 2, indicating some evidence supporting safety without sufficient data backing efficacy."

Answered by AI

Are new participants being enrolled in this study at this time?

"Indeed, the information from clinicaltrials.gov indicates that this trial is currently seeking participants. The trial was initially posted on April 1st, 2024 and underwent its last revision on the same day. This study aims to recruit 75 individuals across four distinct sites."

Answered by AI

Are multiple medical centers in Canada conducting this research trial?

"This clinical study is operational at 4 different sites, with clinics located in Bellaire, Huntington Beach, Austin and several other undisclosed locations. Opting for the nearest clinic will reduce travel constraints post-enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of the Efficacy and Safety of KUS121 in Participants With Acute Non-Arthritic Central Retinal Artery Occlusion (CRAO)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06178055.

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