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

NCT06487039 | Recruiting Phase 2 DMC

• 1 other identifier: EB-203-201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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)

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Keywords

nAMD; eye

Outcome Measures

Primary Outcomes (1)

• Change in central retinal thickness (CRT)

  Change in central retinal thickness (CRT) measured by OCT at Week 12 compared to baseline.

  Week 12

Secondary Outcomes (4)

• Change in BCVA

  Weeks 4, 8, 12

• Change Proportion (%) in BCVA

  Weeks 4, 8, 12

• Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid

  Weeks 4, 8, 12

• Proportion (%) of subjects who received rescue medication

  Weeks 4, 8, 12

Study Arms (2)

Group A

EXPERIMENTAL

EB-203 2% QID

Drug: EB-203

Group B

EXPERIMENTAL

EB-203 4% QID

Drug: EB-203

Interventions

EB-203 DRUG

Subjects will receive EB-203 according to the following dosage and administration method for each treatment group.

Group A; Group B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 50 years or older
• 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)
• Subjects who voluntarily signed the informed consent form (ICF) after receiving the information on this study

You may not qualify if:

• Subjects with confirmed nAMD requiring standard treatment in both eyes (however, dry AMD in the non-study eye may be enrolled)
• 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)
• 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
• Subjects who have received intravitreal treatment using steroids
• 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
• Subjects with vitreous hemorrhage in the study eye
• Subjects who have undergone vitrectomy
• Subjects with a history of retinal detachment, congenital disease, or treatment and/or surgical history for retinal detachment
• Subjects with scarring, fibrosis, or atrophy involving the center of the fovea of the study eye
• Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)

Sponsors & Collaborators

• EyebioKorea, Inc.: lead

Study Sites (5)

Busan Paik Hospital, Inje University

Busan, 47392, South Korea

RECRUITING

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Yeungnam University Medical Center

Daegu, 42415, South Korea

RECRUITING

Kim's Eye Hospital

Seoul, 08858, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 08858, South Korea

RECRUITING

Study Officials

• Kyu Hyeong Park

  Seoul National University HospitalSeoul National University Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SUYEON KIM

CONTACT

1047070314; suyeon@eyebiokorea.com

YUNSEOK CHO

CONTACT

70-4129-7497; yscho@eyebiokorea.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group A: EB-203 2% QID Group B: EB-203 4% QID

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be shared starting 6 months after the trial ends and will be available for at least 5 years.
• 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.

Locations

KR (5)