Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536491
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Subject- and Evaluator-Masked Phase 2 Clinical Trial Comparing EC-104 Intravitreal Implant to Ozurdex for the Treatment of Diabetic Macular Edema BETTIS-1
Status:
NOT_YET_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:
BETTIS-1
Brief Summary:
This is a prospective randomized subject- and evaluator-masked Phase 2 multicenter study comparing the safety and efficacy of EC-104-6M high-dose fluocinolone acetonide FA 014 mg implant and EC-104-4M low-dose FA 0092 mg implant to Ozurdex dexamethasone intravitreal IVT implant 07 mg in subjects with diabetic retinopathy DR and center-involving diabetic macular edema DME with prior suboptimal clinical response to IVT anti-VEGF therapy who have been previously treated with locally administered corticosteroids without a clinically significant rise in intraocular pressure IOP
Detailed Description:
Approximately 75 subjects who meet entry criteria will be randomized 111 to EC-104-6M high-dose FA 014 mg implant or EC-104-4M low-dose FA 0092 mg implant or Ozurdex dexamethasone IVT implant 07 mg with the goal of achieving approximately 20 subjects per group with a positive therapeutic response in their study eyes who are evaluable in the primary endpoint analysis to assess efficacy Subjects with a positive therapeutic response at Week 4 will be included in the primary and secondary endpoint analyses to assess efficacy for Time to recurrent disease Subjects who do not achieve a positive therapeutic response will be classified as suboptimal responders While suboptimal responders will not be included in the primary and the secondary endpoint analyses to assess efficacy for Time to recurrent disease they will remain in the study and will be followed prospectively with inclusion in the remaining endpoints to assess efficacy and all safety endpoint analyses
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