Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470373
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-11
Brief Title:
A Phase 3 Clinical Trial to Compare RBS-001 to Eylea in Subjects With Neovascular Age-Related Macular Degeneration
Sponsor:
Rophibio Inc
Organization:
Rophibio Inc
Study Overview
Official Title:
A Phase 3 Clinical Trial to Compare Efficacy Safety Tolerability and Immunogenicity of RBS-001 to Eylea in Subjects With Neovascular Age-Related Macular Degeneration
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
This clinical study is designed to demonstrate the equivalence of the two Investigational Products by comparing the efficacy safety tolerability and immunogenicity of RBS-001 and Eylea in subjects with Neovascular age-related macular degeneration
Detailed Description:
This is a phase 3 clinical trial to compare efficacy safety tolerability and immunogenicity of RBS-001 to Eylea in subjects with neovascular age-related macular degeneration A total of 434 subjects will be enrolled in the sponsor-selected study institutions
The test group will be 217 subjects including approximately 20 subjects for the exploratory assessment of PK and the control group will be 217 subjects including approximately 20 subjects for the exploratory assessment of PK
Overall study period is approximately 24 months from the date of approval by the Institutional Review Board IRB or the Independent Ethics Committee IEC Study period for individual subjects is approximately 56 weeks up to 28 days of screening 48 weeks of treatment 4 weeks of follow-up
The test group will be 217 subjects including approximately 20 subjects for the exploratory assessment of PK and the control group will be 217 subjects including approximately 20 subjects for the exploratory assessment of PK
Overall study period is approximately 24 months from the date of approval by the Institutional Review Board IRB or the Independent Ethics Committee IEC Study period for individual subjects is approximately 56 weeks up to 28 days of screening 48 weeks of treatment 4 weeks of follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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