Eye drops could replace needles for blinding eye disease?
NCT ID NCT06969001
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial tested the safety of SCAI-005, an eye drop containing axitinib, in 48 healthy Korean adults. The goal was to see if the drug is safe and how it behaves in the body when given as single or multiple doses. It is a first step toward a potential needle-free treatment for wet age-related macular degeneration, a leading cause of vision loss.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- axitinib (as eye drops)
- What this could lead to
- If this early safety study succeeds, it could pave the way for a non-invasive eye drop treatment for wet age-related macular degeneration, potentially reducing the need for frequent injections.
- What could go wrong
- This is a very early Phase 1 trial in only 48 healthy people, not patients with the disease. It only tests safety and how the drug moves through the body, not whether it works for wet AMD. Many drugs fail in later stages.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
48 people
The number who actually took part.
- Started
-
May 2025
- Finished
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Sep 2025
- Lead sponsor
-
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
-
19 to 50 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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: * Healthy adult subjects aged 19 to 50 years at the time of screening * Male subjects with a body weight of 55.0 kg or more, Female subjects with a body weight of 50kg or more, and within ±20% of ideal body weight at the time of screening * Subject who voluntarily agrees to participate in this study and has given a written informed consent, after fully understanding the detailed explanation of this study Exclusion Criteria: * Subjects with symptoms suggestive of an acute disease at the time of screening * Subjects with clinically significant and active diseases related to cardiovascular system, gastrointestinal system, respiratory system, endocrine system, neuropsychiatric system, hematologic/oncologic system * Subjects meeting any of the following criteria based on examination during screening: 1. AST, ALT \> 1.5 X ULN 2. Total bilitubin \> 1.5 X ULN 3. eGFR (estimated Glomerular Filtration Rate) \< 90 mL/min/1.73 m2 4. serological test result = positive * Subjects with systolic blood pressure of 90 mmHg or less, or 150 mmHg or more, or diastolic blood pressure of 50 mmHg or less, or 100 mmHg or more after sitting for at least 5 minutes during screening (Visit 1) * Subjects meeting any of the following criteria based on ophthalmological examination during screening: 1. Best corrected visual acuity \< 0.6 2. IOP \> 21 mmHg 3. difference in IOP between both eyes \> 4mmHg 4. subjects who are assessed ineligible due to abnormal findings in other ophthalmonlogical examinations * History or suspicion of conditions affecting visual organs such as keratitis, iritis, uveitis, retinitis, dry eye syndrome, strabismus within 12months prior to screening visit * Ophthalmologic surgery within 12 months prior to screening visit * Subjects with acute or chronic eye diseases requiring topical eyedrops at the time of screening * Experience of adverse effects from contact lens use, or contact lens use within one month prior to screening visit, or inability to abstain from contact lens use during the clinical trial * Subjects with a history of drug abuse or a positive result on a urine drug test at screening * Subjects with a history of hypersensitivity to the investigational drug, or to drugs in the same class as the active ingredients * Subjects who have participated in another clinical trial and received an investigational drug within 6 months prior to the anticipated first dose * Subjects who have taken drug metabolism inducers or inhibitors, such as barbiturates, within one month prior to the expected first dosing date * Subjects who have donated whole blood within 2 months, or component blood within 20 days * Subjects who have taken any prescription drugs or oriental medicine within 2 weeks of the expected first dosing date, or any over-the-counter drugs or vitamins within 1 week of the expected first dosing date * Subjects unable to restrict grapefruit or grapefruit-containing food consumption from 7 days prior to the anticipated first dose through the duration of the clinical trial. * Subjects who regularly consume caffeine (e.g., coffee or green tea more than 5 units/day) or are unable to abstain from caffeine-containing foods from 24 hours prior to hospitalization to discharge * Subjects who have consumed alcohol regularly (more than 210g/week) or are unable to abstain from alcohol from 24 hours prior to hospitalization to discharge * Subjects who have regularly smoked (including e-cigarettes, more than 10 cigarettes/day) or are unable to abstain from 24 hours prior to hospitalization to discharge * Female participants who are pregnant, or are breastfeeding * Subjects who, during the entire clinical trial period and for at least 90 days after the last dose of the investigational drug, cannot or do not agree to use medically acceptable double contraception methods, or who do not agree to refrain from donating sperm during this period * Subjects deemed unsuitable for participation by the investigator for other reasons
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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
-
The Catholic University, Seoul ST. Mary's Hospital
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New eye drug goes Head-to-Head with standard treatment for wet AMD
- New eye drug goes Head-to-Head with standard care for wet AMD
- Eye drops could replace injections for wet AMD
- Could eye drops replace injections for a leading cause of blindness?
- Eye injection burden varies by disease, study finds
- New hope for wet AMD patients: a simple pill may drain stubborn eye fluid