Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04576689
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2020-09-30
Brief Title:
Safety and Efficacy of IBE-814 Intravitreal IVT Implant - A Sustained Low Dose Dexamethasone Therapy
Sponsor:
Ripple Therapeutics Pty Ltd
Organization:
Ripple Therapeutics Corporation
Study Overview
Official Title:
RIPPLE-1 Evaluation of Safety and Efficacy of the IBE-814 Intravitreal Implant in Patients With Diabetic Macular Oedema and Macular Oedema Due to Retinal Vein Occlusion
Status:
COMPLETED
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 trial is a phase II multi-center single-masked assessors dose-ranging study designed to evaluate the comparative safety and preliminary efficacy of two dosage regimens of the IBE-814 IVT Dexamethasone Implant in patients with DMO and RVO
Detailed Description:
The study will enroll up to 50 patients up to 50 eyes with DMO or RVO across two treatment groups Low Dose and High Dose Patients will be identified and recruited through the clinic population of ophthalmology centers in Australia and New Zealand specializing in the diagnosis and treatment of retinal diseases All patients will be followed for a planned evaluation period of 18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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