NCT06314217

Everads Injector in Suprachoroidal Administration of TA Suspension, for Treatment of Patients With DME

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Everads Therapy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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. Baseline/Injection 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

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DEVICE	Everads Injector	Single suprachoroidal injection of triamcinolone acetonide, 4 mg in 100 μl using Everads Injector

Timeline

• Start date: 2024-02-18
• Primary completion: 2025-03-26
• Completion: 2025-03-26
• First posted: 2024-03-15
• Last updated: 2025-05-31

Locations

1 site across 1 country: Israel