Diabetic Macular EdemaPhase 2OXEYENCT05697809
Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema
A Phase 2 study testing OXU-001, Semi-automated suprachoroidal illuminated microcatheter and Ozurdex® Ophthalmic Intravitreal Implant in people with Diabetic Macular Edema, run by Oxular Limited at 9 sites in 2 countries.
Trial summary
The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis® illuminated microcatheterization device compared with intravitreal dexamethasone implant… 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?
- OXU-001, Semi-automated suprachoroidal illuminated microcatheter and Ozurdex® Ophthalmic Intravitreal Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 7 Aug 2023to 5 Dec 2024
- Phase
- Phase 2
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 between 34 and 78 (early treatment of diabetic retinopathy study) ETDRS letters
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 16 weeks prior to screening
- Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye
- Prior treatment with anti-VEGF in the study eye:
- Treatment naïve group (Part B), any IVT anti-VEGF treatments in the study eye are exclusionary regardless of the time interval since injection.
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- Previously treated group (Part A and B), subjects in the previously treated group are excluded if they meet any of the below criteria for the study eye at screening:
- Subject has received less than 3 anti-VEGF injections since treatment initiation (at least three injections must have been received for eligibility).
- Time interval between the first anti-VEGF injection and screening is more than 40 weeks.
- Last injection with ranibizumab or bevacizumab within 4 weeks prior to screening.
- Last injection with aflibercept within 8 weeks prior to screening.
- Last injection with faricimab or brolucizumab within 12 weeks prior to screening.
- Prior treatment with SUSVIMO (Port Delivery System) implant is exclusionary.
- Prior ocular treatment with steroid injections (periocular, subtenon, intravitreal) or intravitreal implants in the study eye.
- Prior treatment with suprachoroidal steroids in the study eye is exclusionary.
- Active malignancy or history of malignancy within the past 5 years
- Uncontrolled diabetes with a hemoglobin A1c (HbA1c) more than 12% or any other uncontrolled systemic disease at screening.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Blue Ocean Clinical Research West
Clearwater, Florida, 33761
Retina Consultants of Texas
Houston, Texas, 77380
Valley Retina Institute, PA
McAllen, Texas, 78503
Retina Consultants of Minnesota
Minneapolis, Minnesota, 55337
University Retina and Macula Associates
Oak Forest, Illinois, 60452
Retinal Research Institute, LLC
Phoenix, Arizona, 85053
Sierra Eye Associates
Reno, Nevada, 89502
Retinal Consultants of Texas - San Antonio
San Antonio, Texas, 78240
Puerto Rico1 site
Emmanuelli Research and Development Center, LLC
Arecibo, 00612
About this study
Official title: A Multi-Center, Randomized, Parallel-Group, Phase 2, Masked, Three-Arm Trial to Compare Safety, Tolerability, Efficacy, and Durability of Two Dose Levels of Suprachoroidal Sustained-Release OXU-001 (Dexamethasone Microspheres; DEXAspheres®) Using the Oxulumis® Illuminated Microcatheterization Device Compared With Intravitreal Dexamethasone Implant (OZURDEX®) in Subjects With Diabetic Macular Edema (OXEYE)
The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis® illuminated microcatheterization device compared with intravitreal dexamethasone implant (OZURDEX®) in subjects with diabetic macular edema.
Read the detailed description
Fifty-two (52) week phase 2 trial with two parts. Part A is an open-label, randomized, single-dose two treatment arm comparison of two dose levels of sustained-release suprachoroidal OXU-001 (DEXAspheres® administered using the Oxulumis® illuminated microcatheterization device) in subjects with Diabetic Macular Edema.
--- Part A was only partially recruited due a non-safety related sponsor decision to stop further recruitment after 3 randomized and treated subjects.
--- Part B is a randomized, masked, active comparator, single-dose, three treatment arm comparison of two dose levels of suprachoroidal OXU-001 and IVT Ozurdex® to evaluate the safety, tolerability, efficacy, and durability in subjects with Diabetic Macular Edema (DME).
--- Part B was not initiated due a non-safety related sponsor decision in Dec 2023.
--- In Part A, after a screening period, approximately 18 adult female or male subjects will be randomized in a 1:1 ratio to receive a single administration of one of two dose levels of OXU-001 (mid-dose or high-dose).
In Part B, after a screening period, approximately 110 adult female or male subjects will be randomized in a 2:2:1 ratio to receive a single administration of one of two dose levels of OXU-001 (Dose 1 or Dose 2) or Ozurdex®.
From Week 12, subjects will be assessed for the need for follow-on treatment. The follow-up period after treatment administration will be up to fifty-two (52) weeks.
- Conditions
- Diabetic Macular Edema
- Being tested
- OXU-001, Semi-automated suprachoroidal illuminated microcatheter, Ozurdex® Ophthalmic Intravitreal Implant
- Keywords
- Macular Edema, Edema, Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, Anti-Inflammatory Agents, Glucocorticoids, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs, Immunosuppressive Agents, Immunologic Factors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Dexamethasone, Suprachoroidal Microcatheterization, Illuminated Microcatheterization, Sustained-Release
- Medical subject headings
- Macular Edema, Edema, Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OXU-001Drug
Also called DEXAspheres®
Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheterDevice
Also called Oxulumis®
Ophthalmic administration device
Ozurdex® Ophthalmic Intravitreal ImplantDrug
Also called intravitreal dexamethasone implant
Ophthalmic dexamethasone intravitreal implant
| Study group | Role | What they receive |
|---|---|---|
| A1: OXU-001 / Mid dose | Experimental | The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied. Receives: Drug: OXU-001; Device: Semi-automated suprachoroidal illuminated microcatheter |
| A2: OXU-001 / High Dose | Experimental | The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied. Receives: Drug: OXU-001; Device: Semi-automated suprachoroidal illuminated microcatheter |
| B1: OXU-001 / Mid Dose | Experimental | The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied. Receives: Drug: OXU-001; Device: Semi-automated suprachoroidal illuminated microcatheter |
| B2: OXU-001 / High Dose | Experimental | The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied. This dose may be adpated based on the outcome of a Week 6 data review of Part A Receives: Drug: OXU-001; Device: Semi-automated suprachoroidal illuminated microcatheter |
| B3: Ozurdex® | Active comparator | A single treatment with intravitreal Ozurdex® Receives: Drug: Ozurdex® Ophthalmic Intravitreal Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Treatment-emergent adverse events are defined as events emerging following administration of study treatment (OXU-001 administered with the Oxulumis suprachoroidal administration device) at Visit 2 (Baseline, Day 0)
Measured: Day 0 up to Week 52
Frequency and Severity of Treatment-emergent Adverse Device Effects
Treatment-emergent adverse device effects are defined as effects emerging following administration of study treatment at Visit 2 (Baseline, Day 0)
Measured: Day 0 up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start7 Aug 2023
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
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
- The trial was designed to include previously IVT anti-VEGF treated (in Part A and B) and treatment-naive (in Part B only) DME subjects. In Part A, approximately 18 subjects will be randomly assigned (ratio 1:1) to receive either a mid-dose or high-dose of suprachoroidal OXU-001. In Part B, approximately 110 subjects will be randomly assigned (ratio 2:2:1) to receive a single treatment of either suprachoroidal OXU-001 Dose 1, or Dose 2 or intravitreal Ozurdex® Note: Due to a non-safety related sponsor decision in Dec 2024 trial recruitment was stopped after only 3 subjects randomized and treated in Part A of the clinical trial. Part B was therefore not initiated.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 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
- NCT05697809
- Sponsor's protocol ID
- OXUCT-102 - OXEYE
- Acronym
- OXEYE
- Status last verified
- Jul 2025
- First submitted
- 13 Jan 2023
- Last updated
- 3 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No