Diabetic Macular EdemaNCT06314217
Everads Injector in Suprachoroidal Administration of TA Suspension, for Treatment of Patients With DME
A study testing Everads Injector in people with Diabetic Macular Edema, run by Everads Therapy at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Everads Injector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Feb 2024to 26 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Everads Injector
- Keywords
- suprachoroidal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everads InjectorDevice
Single suprachoroidal injection of triamcinolone acetonide, 4 mg in 100 μl using Everads Injector
| Study group | Role | What they receive |
|---|---|---|
| Open-label prospective device study | Experimental | Treatment of previously treated patients diagnosed with diabetic macular edema (DME) Receives: Device: Everads Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (2)
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.
Measured: Injection day
Change from baseline in central macular thickness
Change from baseline in central macular thickness (CMT), as measured by OCT.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start18 Feb 2024
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Everads Injector: For targeted suprachoroidal delivery of therapy
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Everads Therapy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barak, MD, Principal investigator, Rambam MCKeren Mano Tamir, MD, Study director, Everads Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314217
- Sponsor's protocol ID
- CL-00002
- Other IDs
- 202330714
- Status last verified
- May 2025
- First submitted
- 5 Mar 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06314217
- Acronym / sponsor ID
- CL-00002
- Conditions
- Diabetic Macular Edema
- Keywords
- suprachoroidal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Everads TherapyIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Everads Injector: For targeted suprachoroidal delivery of therapy
| Arm | Type | Receives |
|---|---|---|
| Open-label prospective device study | Experimental | Device: Everads InjectorTreatment of previously treated patients diagnosed with diabetic macular edema (DME) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everads InjectorSingle suprachoroidal injection of triamcinolone acetonide, 4 mg in 100 μl using Everads Injector | Device | Open-label prospective device study |
Primary outcome
Frequency of treatment-emergent adverse events
Time frame: 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
Time frame: 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.
2 secondary outcomes
Confirmation of TA delivery into the suprachoroidal space
Time frame: Injection day
Change from baseline in central macular thickness
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barak, MD principal investigator
Rambam MC
Keren Mano Tamir, MD study director
Everads Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everads Injector in people with Diabetic Macular Edema, run by Everads Therapy at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment-emergent adverse events (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.