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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Device: Everads Injector

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

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adi Hoggeg; Phone Number: 972544708066; Email: adibh@everads-therapy.com

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Rambam MC
    • Contact: Meital Abecassis; Phone Number: 047772668
    • Principal Investigator: Yoreh Barak, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Males and females ≥ 18 years of age with a diagnosis of type 1 or type 2 diabetes mellitus.
2. Diagnosis of DME with confirmed central involvement of ≥ 320 µm for males and ≥ 305 µm for females on Spectralis (Heidelberg) or ≥ 305 µm for males and ≥ 290 µm for females with Cirrus (Zeiss) by spectral domain optical coherence tomography (SD-OCT), verified at the screening visit.
3. First three patients: ETDRS BCVA letter score of worse than 35 (Snellen equivalent of 20/200 imperial or 6/60 metric) in the study eye, and ETDRS BCVA of 60 (Snellen equivalent of 20/63 imperial or 6/19 metric) or better in the fellow eye. Remaining patients: ETDRS BCVA letter score of worse than 50 (Snellen equivalent of 20/100 imperial or 6/30 metric) in the study eye, and ETDRS BCVA of 60 (Snellen equivalent of 20/63 imperial or 6/19 metric) or better in the fellow eye.
4. Have shown no response to three previous Intravitreal (IVT) treatments with anti-vascular endothelial growth factor (VEGF) agents.

Key Exclusion Criteria:

1. Evidence of macular edema of any cause other than diabetic retinopathy in the study eye.
2. Prior treatment with pan-retinal photocoagulation or focal laser photocoagulation in the study eye within 90 days of screening visit.
3. Intraocular pressure ≥ 21 mmHg or uncontrolled glaucoma (open-angle or angle-closure) in the study eye.
4. History of any prior ophthalmic surgeries in the study eye within 90 days of the screening visit.
5. Previous treatment for DME in the study eye with any intravitreal injection in the 30 days prior to the screening visit.
6. Any previous treatment with Ozurdex® implant in past 6 months.
7. Any previous treatment with Iluvien® or Retisert™.
8. Current iris neovascularization, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane that contributes to macular edema in the study eye, per PI discretion.
9. Uncontrolled blood pressure.
10. HbA1c >12%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-label prospective device study; Treatment of previously treated patients diagnosed with diabetic macular edema (DME)	Device: Everads Injector; Single suprachoroidal injection of triamcinolone acetonide, 4 mg in 100 μl using Everads Injector

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of treatment-emergent adverse events	Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (6 weeks) TEAEs are defined as events that emerge following administration of TA via the Everads Injector.	6 weeks
Frequency of adverse device effects	Frequency of adverse device effects and frequency of serious adverse device effects (SADEs) throughout the study period (6 weeks) Adverse device effects and SADEs are defined as effects that emerge following the use of the Everads Injector.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmation of TA delivery into the suprachoroidal space	Confirmation of TA delivery into the suprachoroidal space, as determined by imaging assessment(s) and/or ocular examination following the injection.	Injection day
Change from baseline in central macular thickness	Change from baseline in central macular thickness (CMT), as measured by OCT.	6 weeks

Collaborators and Investigators

• Sponsor: Everads Therapy
• Investigators: Principal Investigator: Barak, MD, PI

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: suprachoroidal
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema
• Other Study ID Numbers: CL-00002; 202330714 (Registry Identifier: MOH ISRAEL)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No