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

Launched by EYEBIOKOREA, INC. · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called EB-203 for people with a condition known as neovascular age-related macular degeneration (nAMD), which affects vision. The main goal of the study is to see how safe EB-203 is and how well it works for improving sight in patients aged 50 and older. If you're an adult in this age group and have been diagnosed with nAMD but do not need standard treatment in both eyes, you might be eligible to participate.

Participants in this trial will receive the new treatment and will be monitored for any side effects or improvements in their vision. To join, you should have a certain level of visual ability, as measured by a specific test, and you need to be able to give informed consent, meaning you understand what the study involves. It’s important to note that people who have received certain other treatments for nAMD in the past may not be eligible. If you choose to participate, you'll be helping researchers learn more about this potential new therapy for improving vision in people with nAMD.

Gender

ALL

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)