Clinical trial NCT06487039: Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neovascular Age-related Macular Degeneration (nAMD)
Keywords: nAMD
eye
Lead sponsor: EyebioKorea, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: EB-203 2% QID Group B: EB-203 4% QID
Primary purpose: TREATMENT

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If a subject meets the criteria for the administration of rescue medication at Visit 3 (Week 2), he/she will be withdrawn from the study.

From Visit 4 (Week4), subjects may be withdrawn from the study based on the withdrawal criteria for each visit or the criteria for the administration of rescue medication.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).

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)

Primary outcomes:
measure: Change in central retinal thickness (CRT)
timeFrame: Week 12
Secondary outcomes:
measure: Change in BCVA
timeFrame: Weeks 4, 8, 12
measure: Change Proportion (%) in BCVA
timeFrame: Weeks 4, 8, 12
measure: Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid
timeFrame: Weeks 4, 8, 12
measure: Proportion (%) of subjects who received rescue medication
timeFrame: Weeks 4, 8, 12
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital, Inje University
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kim's Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University HospitalSeoul National University Hospital
name: Kyu Hyeong Park
role: STUDY_CHAIR
affiliation: Kim's Eye Hospital
name: JaeHui Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: Iksoo Byon
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeungnam University Hospital
name: Min Sagong
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Dong Geun Kim
role: PRINCIPAL_INVESTIGATOR
References: