NCT06487039

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: EyebioKorea, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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 If a subject meets the criteria for the administration of rescue medication at Visit 3 (Week 2), he/she will be withdrawn from the study. From Visit 4 (Week4), subjects may be withdrawn from the study based on the withdrawal criteria for each visit or the criteria for the administration of rescue medication. If a subject who meets the criteria for the administration of rescue medication for each visit is withdrawn from the study, he/she will be administered the anti-VEGF drug aflibercept (product name: Eylea Injection®) once (intraocular injection).

Conditions

• Neovascular Age-related Macular Degeneration (nAMD)

Interventions

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

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-08-01
• Completion: 2026-01-01
• First posted: 2024-07-05
• Last updated: 2024-08-27

Locations

5 sites across 1 country: South Korea