Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487039
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-27
Brief Title:
Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
Sponsor:
EyebioKorea Inc
Organization:
EyebioKorea Inc
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 inclusionexclusion criteria will be randomized in a 11 ratio into Group AEB-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 heshe 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 heshe will be administered the anti-VEGF drug aflibercept product name Eylea Injection once intraocular injection
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 inclusionexclusion criteria will be randomized in a 11 ratio into Group AEB-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 heshe 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 heshe will be administered the anti-VEGF drug aflibercept product name Eylea Injection once intraocular injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None