Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04684394
Status:
TERMINATED
Last Update Posted:
2022-10-31
First Post:
2020-12-21
Brief Title:
A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration
Sponsor:
Gemini Therapeutics Inc
Organization:
Gemini Therapeutics Inc
Study Overview
Official Title:
A Multicenter Multiple-Dose Study in Neovascular Age-related Macular Degeneration nAMD to Evaluate the Safety Tolerability Pharmacodynamics Immunogenicity and Clinical Effect of Repeat Intravitreal IVT Injections of GEM103 as an Adjunct to Standard of Care Aflibercept Therapy
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to investigate the safety and tolerability of GEM103 IVT injection standard of care vs sham standard of care
Detailed Description:
This is a Phase 2a multi-center multiple dose study in subjects with Neovascular Age-related Macular Degeneration nAMD to investigate the safety and tolerability of GEM103 IVT injection standard of care vs sham standard of care
Subjects will undergo clinical and ophthalmic assessments for determination of inclusion in the study and who meet all eligibility criteria will be enrolled
Subjects will undergo clinical and ophthalmic assessments for determination of inclusion in the study and who meet all eligibility criteria will be enrolled
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