NCT06314217Completed
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
Source: ClinicalTrials.gov · Last updated 31 May 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 5 Mar 2024
- Start date
- Feb 2024
- Primary completion date
- Mar 2025
- Lead sponsor
- Everads Therapy
- Diseases
- Diabetic eye disease
- NCT number
- NCT06314217
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From Feb 2024 to the primary completion date, Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with pan-retinal photocoagulation or focal laser photocoagulation in the study eye within 90 days of screening visit.
- 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™.
Other illness
- Current iris neovascularization, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane that contributes to macular edema in the study eye, per PI discretion.
Lab values
- HbA1c \>12%.
Other
- Evidence of macular edema of any cause other than diabetic retinopathy in the study eye.
- Intraocular pressure ≥ 21 mmHg or uncontrolled glaucoma (open-angle or angle-closure) in the study eye.
- Uncontrolled blood pressure.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rambam MC Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.