Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
NCT ID: NCT06487039
Last Updated: 2024-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2024-08-01
2026-01-31
Brief Summary
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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)
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Detailed Description
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Subjects who have been informed about the study and have voluntarily agreed to sign to participate in the study will be screened.
Final subjects who meet the inclusion/exclusion criteria will be randomized in a 1:1 ratio into Group A(EB-203 2%, 4 times a day) and Group B (EB-203 4%, 4 times a day).
Randomization will be performed using the study institution (hereinafter "institution") as a stratification factor.
Subjects will receive the investigational products according to the group to which they are randomized.
Safety and tolerability will be assessed for 12 weeks after randomization. Efficacy will be assessed at Weeks 4, 8, and 12. In addition, subjects will be monitored by visiting the institution 4 weeks after the last dose of the investigational product (Visit 8).
If a subject meets the criteria for the administration of rescue medication at Visit 3 (Week 2), he/she will be withdrawn from the study.
From Visit 4 (Week4), subjects may be withdrawn from the study based on the withdrawal criteria for each visit or the criteria for the administration of rescue medication.
If a subject who meets the criteria for the administration of rescue medication for each visit is withdrawn from the study, he/she will be administered the anti-VEGF drug aflibercept (product name: Eylea Injection®) once (intraocular injection).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A
EB-203 2% QID
EB-203
Subjects will receive EB-203 according to the following dosage and administration method for each treatment group.
Group B
EB-203 4% QID
EB-203
Subjects will receive EB-203 according to the following dosage and administration method for each treatment group.
Interventions
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EB-203
Subjects will receive EB-203 according to the following dosage and administration method for each treatment group.
Eligibility Criteria
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Inclusion Criteria
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
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)
50 Years
ALL
No
Sponsors
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EyebioKorea, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kyu Hyeong Park
Role: STUDY_CHAIR
Seoul National University HospitalSeoul National University Hospital
JaeHui Kim
Role: PRINCIPAL_INVESTIGATOR
Kim's Eye Hospital
Iksoo Byon
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Hospital
Min Sagong
Role: PRINCIPAL_INVESTIGATOR
Yeungnam University Hospital
Dong Geun Kim
Role: PRINCIPAL_INVESTIGATOR
Inje University
Locations
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Busan Paik Hospital, Inje University
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Kim's Eye Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EB-203-201
Identifier Type: -
Identifier Source: org_study_id
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