Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314217
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-05
Brief Title:
Everads Injector in Suprachoroidal Administration of TA Suspension for Treatment of Patients With DME
Sponsor:
Everads Therapy
Organization:
Everads Therapy
Study Overview
Official Title:
Everads Injector in Suprachoroidal Administration of a Triamcinolone Acetonide TA Suspension Approved for Intraocular Injection for the Treatment of Patients With Diabetic Macular Edema An Open-label Safety and Performance Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-03
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 is an open-label pilot device study The aim of the study is to evaluate the safety and performance of Everads Injector following single injection of suspension approved for ocular use into the suprachoroidal space
The study population is patients diagnosed with diabetic macular edema DME that were previously treated 10 adult subjects are expected to be enrolled based on the inclusion-exclusion criteria
The study will involve 6 visits during a period of 6 weeks
The study population is patients diagnosed with diabetic macular edema DME that were previously treated 10 adult subjects are expected to be enrolled based on the inclusion-exclusion criteria
The study will involve 6 visits during a period of 6 weeks
Detailed Description:
The study involves 6 visits Screening Visit Visit 1 Day -6 to 0 Baseline and Injection Visit Visit 2 Day 1 Follow up visits Visit 3 Day 3 1 Days Visit 4 Day 14 3 Days Visit 5 Day 28 3 Days End of Trial Visit 6 Day 42 3 Days
Patient eligibility will be assessed at screening and the study eye will be determined
BaselineInjection Visit will include a pre-injection examination injection of TA and post-injection examination The study eye will receive the suprachoroidal injection of TA injectable suspension approved for ocular use The Everads Injector will be used for a single administration of 100 µl 4 mg of TA into the suprachoroidal space in the treatment eye
Injections using Everads Injector will be performed by trained and qualified investigators after training by Sponsor experts
Study assessments include physical examination vital signs medical ocular history AE and concomitant medication assessment
Ophthalmological examination include
Best-corrected visual acuity BCVA using the Early Treatment of Diabetic Retinopathy Study ETDRS Visual Acuity Chart
Intraocular Pressure
Optical coherence tomography OCT
Fundus photography
Fluorescein angiography
ICG angiography
Slit-lamp biomicroscopy
Dilated indirect ophthalmoscopy
Subject will be followed for 42 days following injection
Patient eligibility will be assessed at screening and the study eye will be determined
BaselineInjection Visit will include a pre-injection examination injection of TA and post-injection examination The study eye will receive the suprachoroidal injection of TA injectable suspension approved for ocular use The Everads Injector will be used for a single administration of 100 µl 4 mg of TA into the suprachoroidal space in the treatment eye
Injections using Everads Injector will be performed by trained and qualified investigators after training by Sponsor experts
Study assessments include physical examination vital signs medical ocular history AE and concomitant medication assessment
Ophthalmological examination include
Best-corrected visual acuity BCVA using the Early Treatment of Diabetic Retinopathy Study ETDRS Visual Acuity Chart
Intraocular Pressure
Optical coherence tomography OCT
Fundus photography
Fluorescein angiography
ICG angiography
Slit-lamp biomicroscopy
Dilated indirect ophthalmoscopy
Subject will be followed for 42 days following injection
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 202330714 | REGISTRY | MOH ISRAEL | None |