Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571045
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab 05 mg in Participants With DME
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Masked Multi-Center 3-Arm Pivotal Phase 23 Study to Evaluate The Efficacy and Safety of Intravitreal EYE103 Compared With Intravitreal Ranibizumab 05mg in Participants With Diabetic Macular Edema
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRUNELLO
Brief Summary:
EYE-RES-102 is a randomized double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control ranibizumab in patients with diabetic macular edema DME
In the first year all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab Beginning at Year 2 the frequency of treatment for participants will shift based on a personalized treatment interval algorithm
Approximately 960 participants will be entered in the study
In the first year all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab Beginning at Year 2 the frequency of treatment for participants will shift based on a personalized treatment interval algorithm
Approximately 960 participants will be entered in the study
Detailed Description:
EYE-RES-102 is a randomized double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control ranibizumab in patients with diabetic macular edema DME
Approximately 960 participants will be entered in the study Participants will be randomized 111 to receive low dose EYE103 high dose EYE103 or 05 mg ranibizumab administered via intravitreal injection In the first year all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab Beginning at Year 2 the frequency of treatment for participants will shift based on a personalized treatment interval PTI algorithm Throughout the 2-year study subjects will be evaluated every 4 weeks including measurement of ETDRS BCVA examination by slit-lamp biomicroscopy fundoscopy and SD-OCT Among other parameters SD-OCT will be used to measure central subfield thickness CST in microns
Approximately 960 participants will be entered in the study Participants will be randomized 111 to receive low dose EYE103 high dose EYE103 or 05 mg ranibizumab administered via intravitreal injection In the first year all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab Beginning at Year 2 the frequency of treatment for participants will shift based on a personalized treatment interval PTI algorithm Throughout the 2-year study subjects will be evaluated every 4 weeks including measurement of ETDRS BCVA examination by slit-lamp biomicroscopy fundoscopy and SD-OCT Among other parameters SD-OCT will be used to measure central subfield thickness CST in microns
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None