Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration

Recruiting now · Phase 2

Conditions studied: Neovascular Age-related Macular Degeneration (nAMD)

In brief

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)

Key facts

Study ID

NCT06487039

Run by

EyebioKorea, Inc.

People needed

50

Starts

2024-08-01

Expected to finish

2026-01-01

Last updated by the study team

2024-08-27

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Busan Paik Hospital, Inje University — Busan, South Korea (enrolling)
• Pusan National University Hospital — Busan, South Korea (enrolling)
• Yeungnam University Medical Center — Daegu, South Korea (enrolling)
• Kim's Eye Hospital — Seoul, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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