Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919693
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2023-06-14
Brief Title:
A 2-part Study Consisting of Multiple Ascending Dose MAD Safety Study and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal IVT EYE103 in Patients With Diabetic Macular Edema DME or Neovascular Age-related Macular Degeneration NVAMD
Sponsor:
EyeBiotech Ltd
Organization:
EyeBiotech Ltd
Study Overview
Official Title:
A 2-part Study Consisting of an Open-label Multiple Ascending Dose MAD Safety Study and a Dose-finding Single-masked Comparative Safety and Preliminary Efficacy Study of Intravitreal IVT EYE103 in a Mixed Population of Participants With Diabetic Macular Edema DME or Neovascular Age-related Macular Degeneration NVAMD
Status:
COMPLETED
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:
AMARONE
Brief Summary:
EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema DME given as monotherapy or neovascular macular degeneration NVAMD given in combination with anti-VEGF
In the first part termed the multiple ascending dose MAD portion of study the safety of EYE103 will be assessed at escalating doses Approximately 12 participants will be entered in this part of the study
In the second part of the study called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared Approximately 80 participants will be entered in this part of the study
In the first part termed the multiple ascending dose MAD portion of study the safety of EYE103 will be assessed at escalating doses Approximately 12 participants will be entered in this part of the study
In the second part of the study called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared Approximately 80 participants will be entered in this part of the study
Detailed Description:
EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema DME given as monotherapy or neovascular macular degeneration NVAMD given in combination with anti-VEGF
In the first part termed the multiple ascending dose MAD portion of study the safety of EYE103 will be assessed at escalating doses Approximately 12 participants will be entered in this part of the study
In the second part of the study called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared Approximately 80 participants will be entered in this part of the study
In the first part termed the multiple ascending dose MAD portion of study the safety of EYE103 will be assessed at escalating doses Approximately 12 participants will be entered in this part of the study
In the second part of the study called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared Approximately 80 participants will be entered in this part of the study
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