NCT06487039 Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
| NCT ID | NCT06487039 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | EyebioKorea, Inc. |
| Condition | Neovascular Age-related Macular Degeneration (nAMD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-08-01 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Trial to Evaluate the Safety and Efficacy of EB-203 in Patients with Neovascular Age-related Macular Degeneration. The purpose of this study is to primarily investigate the safety and tolerability of EB-203 by dose in patients with neovascular Age-related Macular Degeneration (nAMD), and to secondarily evaluate the clinical efficacy. Subject to Adults aged 50 years or older and Neovascular age-related macular degeneration (nAMD)
Eligibility Criteria
Inclusion Criteria: 1. Adults aged 50 years or older 2. Subjects with a best corrected visual acuity (BCVA) score between 25 and 73, measured by the Early Treatment of Diabetic Retinopathy Study(ETDRS) chart, at a distance of 4 m during the screening (equivalent to 20/40 to 20/320 in the Snellen chart) 3. Subjects who voluntarily signed the informed consent form (ICF) after receiving the information on this study Exclusion Criteria: 1. Subjects with confirmed nAMD requiring standard treatment in both eyes (however, dry AMD in the non-study eye may be enrolled) 2. Subjects who have received ocular or systemic treatment, such as photodynamic therapy (PDT) or laser photocoagulation, or have undergone a surgical operation for nAMD (however, health functional foods, vitamin supplements, etc., are excluded) 3. Subjects whose study eye has been treated with anti-vascular endothelial growth factor (anti-VEGF) drugs (e.g. ranibizumab, bevacizumab, aflibercept, etc.) or a combination therapy for the treatment of nAMD prior to screening 4. Subjects who have received intravitreal treatment using steroids 5. Subjects who have a subretinal hemorrhage in ≥ 50% of the total lesion area or who have a hemorrhage in the subfoveal region of the study eye and in whom the hemorrhage area is ≥ 1 optic disk area 6. Subjects with vitreous hemorrhage in the study eye 7. Subjects who have undergone vitrectomy 8. Subjects with a history of retinal detachment, congenital disease, or treatment and/or surgical history for retinal detachment 9. Subjects with scarring, fibrosis, or atrophy involving the center of the fovea of the study eye 10. Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)
Contact & Investigator
Kyu Hyeong Park
STUDY CHAIR
Seoul National University HospitalSeoul National University Hospital
Frequently Asked Questions
Who can join the NCT06487039 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Neovascular Age-related Macular Degeneration (nAMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06487039 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06487039 currently recruiting?
Yes, NCT06487039 is actively recruiting participants. Contact the research team at suyeon@eyebiokorea.com for enrollment information.
Where is the NCT06487039 trial being conducted?
This trial is being conducted at Busan, South Korea, Busan, South Korea, Daegu, South Korea, Seoul, South Korea and 1 additional location.
Who is sponsoring the NCT06487039 clinical trial?
NCT06487039 is sponsored by EyebioKorea, Inc.. The principal investigator is Kyu Hyeong Park at Seoul National University HospitalSeoul National University Hospital. The trial plans to enroll 50 participants.