Diabetic Macular EdemaPhase 2CAPENCT05512962
Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema
A Phase 2 study testing Triamcinolone Acetonide and Semi-automated Suprachoroidal Microcatheter in people with Diabetic Macular Edema, run by Oxular Limited at 6 sites in United States.
Trial summary
The purpose of this clinical trial is to evaluate the safety and tolerability of suprachoroidal microcatheterization with the Oxulumis® device for a randomized treatment with two dose levels of Triesence® in subjects with Diabetic Macular Edema. 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?
- Triamcinolone Acetonide and Semi-automated Suprachoroidal Microcatheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Aug 2022to 30 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Type 1 or Type 2 diabetes mellitus.
- Diabetic macular edema involving the center of the fovea in the study eye
- Best-corrected visual acuity in the study eye of ≤73 (early treatment of diabetic retinopathy study) ETDRS letters (approximate Snellen equivalent of 20/40 or worse)
- Short-lived, limited, or no response to prior ocular injection therapy
Who cannot join
- Macular edema is considered due to a cause other than diabetes mellitus in the study eye.
- Condition, in the study eye, in which visual acuity is not expected to improve from the resolution of macular edema
- Macular laser photocoagulation or panretinal laser photocoagulation in the study eye performed within sixteen (16) weeks prior to screening.
- Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye.
- Active malignancy or history of malignancy within the past five years.
- Prior intravitreal (IVT) treatment with anti-Vascular endothelial growth factor (VEGF) in the study eye: last injection within four weeks, before screening
Show all 10Show fewer
- Prior ocular treatment with steroids in the study eye: last injection (intra- or periocular) with triamcinolone acetonide within three (3) months, with dexamethasone implant (Ozurdex®) within six (6) months before screening.
- Prior treatment with longer duration steroid implants (e.g., fluocinolone acetonide IVT implant, Iluvien®) is exclusionary.
- Prior treatment with suprachoroidal steroids is exclusionary.
- Uncontrolled diabetes with a hemoglobin A1c (HbA1c) > 12% or any other uncontrolled systemic disease at screening.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Austin Retina Associates
Austin, Texas, 78705
California Retina Consultants
Bakersfield, California, 93309
Retina Consultants of Texas - The Woodlands
Houston, Texas, 77384
Retina Consultants of Texas - Bellaire
Houston, Texas, 77401
Retina Consultants of Minnesota
Minneapolis, Minnesota, 55435
Retina Consultants of Texas - San Antonio
San Antonio, Texas, 78240
About this study
Official title: A Multi-Center, Randomized, Two-Arm, Parallel-Group, Single-masked, 24-week, Clinical Trial to Evaluate Safety and Tolerability of Two Dose Levels of Suprachoroidal Triamcinolone Acetonide Administered With the Oxulumis® Ophthalmic Administration Device in Subjects With Diabetic Macular Edema
The purpose of this clinical trial is to evaluate the safety and tolerability of suprachoroidal microcatheterization with the Oxulumis® device for a randomized treatment with two dose levels of Triesence® in subjects with Diabetic Macular Edema.
Read the detailed description
Twenty-four (24) week, randomized, two-arm, single-masked, clinical trial to evaluate safety, tolerability, and to explore the efficacy of two dose levels of suprachoroidal triamcinolone acetonide suspension (Triesence®, 2.4 mg, and 4.0mg) administered using the Oxulumis® microcatheterization device in subjects with previously treated Diabetic Macular Edema.
After a screening period, approximately 20 eligible Diabetic Macular Edema subjects will be treated using a 1:1 ratio to receive a single administration of one of two dose levels of triamcinolone acetonide (low dose, 2.4mg. or mid-dose, 4.0mg, respectively). If for any reasons treatment in randomized subjects cannot be completed, additional consecutive subjects will be randomized until the target number of approximately 20 treated subjects is reached.
From Week 4, subjects will be assessed for the need for follow-on treatment. The follow-up period after treatment administration will be up to twenty-four (24) weeks.
- Conditions
- Diabetic Macular Edema
- Being tested
- Triamcinolone Acetonide, Semi-automated Suprachoroidal Microcatheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called Triesence®
Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal MicrocatheterDevice
Also called Oxulumis®
Ophthalmic Adminstration Device
| Study group | Role | What they receive |
|---|---|---|
| Suprachoroidal Triamcinolone acetonide 2.4mg | Experimental | The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied. Receives: Drug: Triamcinolone Acetonide; Device: Semi-automated Suprachoroidal Microcatheter |
| Suprachoroidal Triamcinolone acetonide 4.0mg | Experimental | The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied. Receives: Drug: Triamcinolone Acetonide; Device: Semi-automated Suprachoroidal Microcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of Triesence® with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
Measured: Day 0 up to Week 24 (per protocol individual trial duration per participant)
Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects
Adverse device effects a are defined as effects that emerge following the start of administration of the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
Measured: Day 0 up to Week 24 (per protocol individual trial duration per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start31 Aug 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Two-Dose Group Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxular Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Friedrich Asmus, MD, Study director, Oxular Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512962
- Sponsor's protocol ID
- OXUCT-103 - CAPE
- Other IDs
- 2022-001533-37
- Acronym
- CAPE
- Status last verified
- Oct 2024
- First submitted
- 20 Aug 2022
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Two-Arm, Parallel-Group, Single-masked, 24-week, Clinical Trial to Evaluate Safety and Tolerability of Two Dose Levels of Suprachoroidal Triamcinolone Acetonide Administered With the Oxulumis® Ophthalmic Administration Device in Subjects With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT05512962
- Acronym / sponsor ID
- CAPE / OXUCT-103 - CAPE
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Oxular LimitedIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Posted 20 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to evaluate the safety and tolerability of suprachoroidal microcatheterization with the Oxulumis® device for a randomized treatment with two dose levels of Triesence® in subjects with Diabetic Macular Edema.
Detailed description
Twenty-four (24) week, randomized, two-arm, single-masked, clinical trial to evaluate safety, tolerability, and to explore the efficacy of two dose levels of suprachoroidal triamcinolone acetonide suspension (Triesence®, 2.4 mg, and 4.0mg) administered using the Oxulumis® microcatheterization device in subjects with previously treated Diabetic Macular Edema.
After a screening period, approximately 20 eligible Diabetic Macular Edema subjects will be treated using a 1:1 ratio to receive a single administration of one of two dose levels of triamcinolone acetonide (low dose, 2.4mg. or mid-dose, 4.0mg, respectively). If for any reasons treatment in randomized subjects cannot be completed, additional consecutive subjects will be randomized until the target number of approximately 20 treated subjects is reached.
From Week 4, subjects will be assessed for the need for follow-on treatment. The follow-up period after treatment administration will be up to twenty-four (24) weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Two-Dose Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Suprachoroidal Triamcinolone acetonide 2.4mg | Experimental | Drug: Triamcinolone Acetonide, Device: Semi-automated Suprachoroidal MicrocatheterThe Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied. |
| Suprachoroidal Triamcinolone acetonide 4.0mg | Experimental | Drug: Triamcinolone Acetonide, Device: Semi-automated Suprachoroidal MicrocatheterThe Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 or Type 2 diabetes mellitus.
- Diabetic macular edema involving the center of the fovea in the study eye
- Best-corrected visual acuity in the study eye of ≤73 (early treatment of diabetic retinopathy study) ETDRS letters (approximate Snellen equivalent of 20/40 or worse)
- Short-lived, limited, or no response to prior ocular injection therapy
Key exclusion criteria (10 listed)
- Macular edema is considered due to a cause other than diabetes mellitus in the study eye.
- Condition, in the study eye, in which visual acuity is not expected to improve from the resolution of macular edema
- Macular laser photocoagulation or panretinal laser photocoagulation in the study eye performed within sixteen (16) weeks prior to screening.
- Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye.
- Active malignancy or history of malignancy within the past five years.
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 |
|---|---|---|
| Triamcinolone AcetonideAlso: Triesence®Single suprachoroidal Administration of Triamcinolone acetonide | Drug | Suprachoroidal Triamcinolone acetonide 2.4mg, Suprachoroidal Triamcinolone acetonide 4.0mg |
| Semi-automated Suprachoroidal MicrocatheterAlso: Oxulumis®Ophthalmic Adminstration Device | Device | Suprachoroidal Triamcinolone acetonide 2.4mg, Suprachoroidal Triamcinolone acetonide 4.0mg |
Primary outcome
Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events
Time frame: Day 0 up to Week 24 (per protocol individual trial duration per participant)
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of Triesence® with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects
Time frame: Day 0 up to Week 24 (per protocol individual trial duration per participant)
Adverse device effects a are defined as effects that emerge following the start of administration of the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Friedrich Asmus, MD study director
Oxular Limited
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triamcinolone Acetonide and Semi-automated Suprachoroidal Microcatheter in people with Diabetic Macular Edema, run by Oxular Limited at 6 sites in United States.
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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events (time frame: Day 0 up to Week 24 (per protocol individual trial duration per participant)). 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 20 Nov 2024.