Everads Injector in Suprachoroidal Administration of TA Suspension, for Treatment of Patients With DME
NCT06314217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-05-31
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
Conditions
Interventions
- DEVICE
-
Everads Injector
Single suprachoroidal injection of triamcinolone acetonide, 4 mg in 100 μl using Everads Injector
Sponsors & Collaborators
-
Everads Therapy
lead INDUSTRY
Principal Investigators
-
Barak, MD · Rambam MC
-
Keren Mano Tamir, MD · Everads Therapy
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-18
- Primary Completion
- 2025-03-26
- Completion
- 2025-03-26
Countries
- Israel
Study Locations
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