Diabetic Macular Edema
Conditions
Keywords
suprachoroidal
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
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
Interventions
DEVICEEverads Injector
Single suprachoroidal injection of triamcinolone acetonide, 4 mg in 100 μl using Everads Injector
Sponsors
Everads Therapy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Everads Injector: For targeted suprachoroidal delivery of therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of treatment-emergent adverse events | 6 weeks | 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. |
| Frequency of adverse device effects | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of TA delivery into the suprachoroidal space | Injection day | Confirmation of TA delivery into the suprachoroidal space, as determined by imaging assessment(s) and/or ocular examination following the injection. |
| Change from baseline in central macular thickness | 6 weeks | Change from baseline in central macular thickness (CMT), as measured by OCT. |
Countries
Israel
Outcome results
None listed