Evaluating EB-203 for treating neovascular age-related macular degeneration
A Randomization, Double-blind, Parallel, Multicenter-Phase 2a Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
This study is testing a new treatment called EB-203 to see if it can safely help people aged 50 and older with neovascular age-related macular degeneration.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | EyebioKorea, Inc. Industry-sponsored |
| Drugs / interventions | ranibizumab, bevacizumab |
| Locations | 5 sites (Busan and 4 other locations) |
| Trial ID | NCT06487039 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of EB-203 in patients with neovascular age-related macular degeneration (nAMD). It is a double-blind, parallel, multicenter Phase 2a study where eligible participants aged 50 and older will be randomized into two groups receiving different concentrations of EB-203. The study will assess safety and tolerability over 12 weeks, with efficacy evaluated at multiple time points. Participants will be monitored for potential withdrawal based on specific criteria during the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 years or older with specific visual acuity scores indicating nAMD.
Not a fit: Patients with confirmed nAMD requiring standard treatment in both eyes or those who have previously received certain ocular treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from nAMD, potentially improving their vision and quality of life.
How similar studies have performed: While this approach is being evaluated in this trial, similar studies targeting nAMD have shown varying degrees of success with different treatments.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Busan and 4 other locations
- Busan Paik Hospital, Inje University — Busan, South Korea (Recruiting)
- Pusan National University Hospital — Busan, South Korea (Recruiting)
- Yeungnam University Medical Center — Daegu, South Korea (Recruiting)
- Kim's Eye Hospital — Seoul, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: JaeHui Kim — Kim's Eye Hospital
- Study coordinator: Suyeon Kim
- Email: suyeon@eyebiokorea.com
- Phone: 1047070314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.