New eye injection shows promise for restoring sight after stroke in the eye
NCT ID NCT06178055
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an experimental drug called KUS121, given as an eye injection, for people who suddenly lost vision due to a blocked artery in the eye (central retinal artery occlusion). The goal was to see if the injection could improve vision better than a sham procedure. The trial included 17 adults who received the treatment within 48 hours of vision loss.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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17 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Austin Retina Associates
Austin, Texas, 78705, United States
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Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
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Florida Retina Institute
Jacksonville, Florida, 32216, United States
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Kaiser Permanente Oakland Med Ctr.
Oakland, California, 94611, United States
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Kresge Eye Institute/Wayne State University
Detroit, Michigan, 48201, United States
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NYEE Infirmary of Mount Sinai
New York, New York, 10003, United States
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Retina Consultants of Texas
San Antonio, Texas, 78240, United States
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Retina Consultants of Texas
The Woodlands, Texas, 77384, United States
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Salehi Retina Institute, Inc
Huntington Beach, California, 92647, United States
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The Retina Partners
Encino, California, 91436, United States
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UH Eye Institute
Cleveland, Ohio, 44106, United States
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