Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With 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

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)

Study Overview

• Status: Recruiting
• Conditions: Neovascular Age-related Macular Degeneration (nAMD)
• Intervention / Treatment: Drug: EB-203

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If a subject meets the criteria for the administration of rescue medication at Visit 3 (Week 2), he/she will be withdrawn from the study.

From Visit 4 (Week4), subjects may be withdrawn from the study based on the withdrawal criteria for each visit or the criteria for the administration of rescue medication.

If a subject who meets the criteria for the administration of rescue medication for each visit is withdrawn from the study, he/she will be administered the anti-VEGF drug aflibercept (product name: Eylea Injection®) once (intraocular injection).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: SUYEON KIM; Phone Number: 82 1047070314; Email: suyeon@eyebiokorea.com
• Study Contact Backup: Name: YUNSEOK CHO; Phone Number: 82 70-4129-7497; Email: yscho@eyebiokorea.com

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Recruiting
    • Pusan National University Hospital
    • Contact: Iksoo Byon; Email: isbyon@naver.com
  • Busan, Korea, Republic of, 47392
    • Recruiting
    • Busan Paik Hospital, Inje University
    • Contact: Dong Geun Kim; Email: kidogu@naver.com
  • Daegu, Korea, Republic of, 42415
    • Recruiting
    • Yeungnam University Medical Center
    • Contact: Min Sagong; Email: msagong@yu.ac.kr
  • Seoul, Korea, Republic of, 08858
    • Recruiting
    • Kim's Eye Hospital
    • Contact: Jae Jui Kim; Email: kjh7997@daum.net
  • Seoul, Korea, Republic of, 08858
    • Recruiting
    • Seoul National University Hospital
    • Contact: KyuHyeong PARK; Email: jiani4@snu.ac.kr
    • Principal Investigator: KyuHyeong PARK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; EB-203 2% QID	Drug: EB-203; Subjects will receive EB-203 according to the following dosage and administration method for each treatment group.
Experimental: Group B; EB-203 4% QID	Drug: EB-203; Subjects will receive EB-203 according to the following dosage and administration method for each treatment group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in central retinal thickness (CRT)	Change in central retinal thickness (CRT) measured by OCT at Week 12 compared to baseline.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BCVA	Change in BCVA at Weeks 4, 8, and 12 compared to baseline.	Weeks 4, 8, 12
Change Proportion (%) in BCVA	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	Weeks 4, 8, 12
Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid	Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid confirmed by OCT at Weeks 4, 8, and 12 weeks compared to baseline	Weeks 4, 8, 12
Proportion (%) of subjects who received rescue medication	Proportion (%) of subjects who received rescue medication (anti-VEGF drug) at each visit	Weeks 4, 8, 12

Collaborators and Investigators

• Sponsor: EyebioKorea, Inc.
• Investigators: Study Chair: Kyu Hyeong Park, Seoul National University HospitalSeoul National University Hospital; Principal Investigator: JaeHui Kim, Kim's Eye Hospital; Principal Investigator: Iksoo Byon, Pusan National University Hospital; Principal Investigator: Min Sagong, Yeungnam University Hospital; Principal Investigator: Dong Geun Kim, Inje University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: eye; nAMD
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: EB-203-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Specify the Plan to Share IPD: All outcome data, including anonymized individual participant data, will be shared.

What IPD Will Be Shared: Demographic information of participants, primary outcome data, secondary outcome data, analysis code, etc.

When Will IPD Be Available: Data will be shared starting 6 months after the trial ends and will be available for at least 5 years.

Under What Conditions Will IPD Be Shared: Data will be available for research purposes only and will be provided to approved researchers.

How to Access the Shared IPD: Researchers must submit a data access request form. Access to the data will be granted upon approval of the request.

• IPD Sharing Time Frame: Data will be shared starting 6 months after the trial ends and will be available for at least 5 years.
• IPD Sharing Access Criteria: Data will be available for research purposes only and will be provided to approved researchers. Researchers must submit a data access request form that includes the research objectives and methodology. Access will be granted upon approval by the data sharing committee.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No