Status:
RECRUITING
Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
Lead Sponsor:
EyebioKorea, Inc.
Conditions:
Neovascular Age-related Macular Degeneration (nAMD)
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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...
Detailed Description
This study is a double-blind, parallel, multicenter-phase 2a study to evaluate the safety and efficacy of EB-203 in patients with nAMD. Subjects who have been informed about the study and have volunt...
Eligibility Criteria
Inclusion
- Adults aged 50 years or older
- 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)
- Subjects who voluntarily signed the informed consent form (ICF) after receiving the information on this study
Exclusion
- Subjects with confirmed nAMD requiring standard treatment in both eyes (however, dry AMD in the non-study eye may be enrolled)
- 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)
- 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
- Subjects who have received intravitreal treatment using steroids
- 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
- Subjects with vitreous hemorrhage in the study eye
- Subjects who have undergone vitrectomy
- Subjects with a history of retinal detachment, congenital disease, or treatment and/or surgical history for retinal detachment
- Subjects with scarring, fibrosis, or atrophy involving the center of the fovea of the study eye
- Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06487039
Start Date
August 1 2024
End Date
January 1 2026
Last Update
August 27 2024
Active Locations (5)
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1
Busan Paik Hospital, Inje University
Busan, South Korea, 47392
2
Pusan National University Hospital
Busan, South Korea, 49241
3
Yeungnam University Medical Center
Daegu, South Korea, 42415
4
Kim's Eye Hospital
Seoul, South Korea, 08858