Neovascular Age-related Macular Degeneration (nAMD)
Conditions
Keywords
nAMD, eye
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 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)
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 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 If a subject meets the criteria for the administration of rescue medication at Visit 3 (Week 2), he/she will be withdrawn from the study. From Visit 4 (Week4), subjects may be withdrawn from the study based on the withdrawal criteria for each visit or the criteria for the administration of rescue medication. If a subject who meets the criteria for the administration of rescue medication for each visit is withdrawn from the study, he/she will be administered the anti-VEGF drug aflibercept (product name: Eylea Injection®) once (intraocular injection).
Interventions
DRUGEB-203
Subjects will receive EB-203 according to the following dosage and administration method for each treatment group.
Sponsors
EyebioKorea, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Group A: EB-203 2% QID Group B: EB-203 4% QID
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in central retinal thickness (CRT) | Week 12 | Change in central retinal thickness (CRT) measured by OCT at Week 12 compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BCVA | Weeks 4, 8, 12 | Change in BCVA at Weeks 4, 8, and 12 compared to baseline. |
| Change Proportion (%) in BCVA | Weeks 4, 8, 12 | Proportion (%) of subjects showing improvement in visual acuity of ≥ 1 line (5 letters on the ETDRS chart), ≥ 2 lines (10 letters on the ETDRS chart), and ≥ 3 lines (15 letters on the ETDRS chart) at Weeks 4, 8, and 12 weeks from baseline |
| Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid | Weeks 4, 8, 12 | Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid confirmed by OCT at Weeks 4, 8, and 12 weeks compared to baseline |
| Proportion (%) of subjects who received rescue medication | Weeks 4, 8, 12 | Proportion (%) of subjects who received rescue medication (anti-VEGF drug) at each visit |
Countries
South Korea
Contacts
Primary ContactSUYEON KIM
Backup ContactYUNSEOK CHO
Outcome results
None listed