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

NCT06314217 | Completed

• 2 other identifiers: CL-00002202330714
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Macular Edema

Keywords

suprachoroidal

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Confirmation of TA delivery into the suprachoroidal space

  Injection day

• Change from baseline in central macular thickness

  6 weeks

Study Arms (1)

Open-label prospective device study

EXPERIMENTAL

Treatment of previously treated patients diagnosed with diabetic macular edema (DME)

Device: Everads Injector

Interventions

Everads Injector DEVICE

Single suprachoroidal injection of triamcinolone acetonide, 4 mg in 100 μl using Everads Injector

Open-label prospective device study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 18 years of age with a diagnosis of type 1 or type 2 diabetes mellitus.
• 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.
• 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.
• Have shown no response to three previous Intravitreal (IVT) treatments with anti-vascular endothelial growth factor (VEGF) agents.

You may not qualify if:

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

Sponsors & Collaborators

• Everads Therapy: lead

Study Sites (1)

Rambam MC

Haifa, Israel

Location

Study Officials

• Barak, MD

  Rambam MC

  PRINCIPAL INVESTIGATOR

• Keren Mano Tamir, MD

  Everads Therapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Everads Injector: For targeted suprachoroidal delivery of therapy

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 15, 2024
• Study Start: February 18, 2024
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)