Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OXU-001 | Drug | Suprachoroidal sustained release dexamethasone acetate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | Day 0 up to Week 52 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Best-Corrected Visual Acuity (BCVA) Compared to Baseline, Visit 2, Day 0 | Assessed using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. All BCVA assessments in the study eye need to be performed in duplicate. The mean of both BCVA assessments was calculated, if both ETDRS letters scores differ by more than 5 letters, the better (higher) ETDRS letter score will be used. | Week 24 |
Inclusion Criteria:
Exclusion Criteria:
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Friedrich Asmus, MD | Oxular Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Research Institute, LLC | Phoenix | Arizona | 85053 | United States | ||
| Blue Ocean Clinical Research West |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | A1: OXU-001 / Mid Dose | 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. OXU-001: Suprachoroidal sustained release dexamethasone acetate Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 27, 2023 | Jul 30, 2025 |
Not provided
Not provided
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.
Not provided
Not provided
Part A is open-label, no masking. Part B is masked for the subject and the outcomes assessing site team and central reading center.
| B3: Ozurdex® | Active Comparator | A single treatment with intravitreal Ozurdex® |
|
|
| Semi-automated suprachoroidal illuminated microcatheter | Device | Ophthalmic administration device |
|
|
| Ozurdex® Ophthalmic Intravitreal Implant | Drug | Ophthalmic dexamethasone intravitreal implant |
|
|
| Mean Change in Best-Corrected Visual Acuity (BCVA) Compared to Baseline, Visit 2, Day 0 | Assessed using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. All BCVA assessments in the study eye need to be performed in duplicate. The mean of both BCVA assessments was calculated, if both ETDRS letters scores differ by more than 5 letters, the better (higher) ETDRS letter score will be used. | Week 52 |
| Mean Change in Central Subfield Thickness (CST) Compared to Baseline, Visit 2, Day 0 | Assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT) using the Central Subfield Thickness values calculated by the software of the SD-OCT devices allowed in the OXEYE clinical trial. | Week 24 |
| Mean Change in Central Subfield Thickness (CST) Compared to Baseline, Visit 2, Day 0 | Assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT) using the Central Subfield Thickness values calculated by the software of the SD-OCT devices allowed in the OXEYE clinical trial. | Week 52 |
| Time Interval to Subjects Requiring follow-on Treatment (From Baseline, Visit 2, Day 0) | Timepoint for meeting pre-specified, protocol-defined criteria of disease activity recurrence. Disease activity was assessed based on Best-Corrected Visual Acuity using the Early Treatment of Diabetic Retinopathy Screening methodology and the central subfield thickness using Spectral-Domain OCT. If criteria were not met throughout Week 52, 365 days were entered. | From Week 12 through Week 52 |
| Clearwater |
| Florida |
| 33761 |
| United States |
| University Retina and Macula Associates | Oak Forest | Illinois | 60452 | United States |
| Retina Consultants of Minnesota | Minneapolis | Minnesota | 55337 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Retina Consultants of Texas | Houston | Texas | 77380 | United States |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | United States |
| Retinal Consultants of Texas - San Antonio | San Antonio | Texas | 78240 | United States |
| Emmanuelli Research and Development Center, LLC | Arecibo | 00612 | Puerto Rico |
| FG001 | A2: OXU-001 / High Dose | 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. OXU-001: Suprachoroidal sustained release dexamethasone acetate Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device |
| FG002 | B1: OXU-001 / Mid Dose | 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. OXU-001: Suprachoroidal sustained release dexamethasone acetate Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device |
| FG003 | B2: OXU-001 / High Dose | 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 OXU-001: Suprachoroidal sustained release dexamethasone acetate Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device |
| FG004 | B3: Ozurdex® | A single treatment with intravitreal Ozurdex® Ozurdex® Ophthalmic Intravitreal Implant: Ophthalmic dexamethasone intravitreal implant |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A1: OXU-001 / Mid Dose | 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. OXU-001: Suprachoroidal sustained release dexamethasone acetate Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device |
| BG001 | A2: OXU-001 / High Dose | 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. OXU-001: Suprachoroidal sustained release dexamethasone acetate Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Best-Corrected Visual Acuity (BCVA) - Study EYE | Mean | Standard Deviation | letters read correctly on ETDRS charts |
| |||||||||||||||
| Central Subfield Thickness (Study Eye) | assessed at the Baseline Visit before treatment | Mean | Standard Deviation | µm |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Safety Analysis Set - - Number of Participants with at least 1 event | Posted | Count of Participants | Participants | No | Day 0 up to Week 52 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | 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) | Safety Analysis Set - - Number of Participants with at least 1 event | Posted | Count of Participants | Participants | Day 0 up to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Change in Best-Corrected Visual Acuity (BCVA) Compared to Baseline, Visit 2, Day 0 | Assessed using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. All BCVA assessments in the study eye need to be performed in duplicate. The mean of both BCVA assessments was calculated, if both ETDRS letters scores differ by more than 5 letters, the better (higher) ETDRS letter score will be used. | Full Analysis Set, Study Eye, Number of Participants with at least 1 post baseline assessment | Posted | Mean | Standard Deviation | letters read correctly on ETDRS charts | Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Change in Best-Corrected Visual Acuity (BCVA) Compared to Baseline, Visit 2, Day 0 | Assessed using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. All BCVA assessments in the study eye need to be performed in duplicate. The mean of both BCVA assessments was calculated, if both ETDRS letters scores differ by more than 5 letters, the better (higher) ETDRS letter score will be used. | Full Analysis Set, Study Eye | Posted | Mean | Standard Deviation | letters read correctly on ETDRS charts | Week 52 |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Change in Central Subfield Thickness (CST) Compared to Baseline, Visit 2, Day 0 | Assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT) using the Central Subfield Thickness values calculated by the software of the SD-OCT devices allowed in the OXEYE clinical trial. | Full Analysis Set, Study Eye | Posted | Mean | Standard Deviation | µm | Week 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Change in Central Subfield Thickness (CST) Compared to Baseline, Visit 2, Day 0 | Assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT) using the Central Subfield Thickness values calculated by the software of the SD-OCT devices allowed in the OXEYE clinical trial. | Full Analysis Set, Study Eye | Posted | Mean | Standard Deviation | µm | Week 52 |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time Interval to Subjects Requiring follow-on Treatment (From Baseline, Visit 2, Day 0) | Timepoint for meeting pre-specified, protocol-defined criteria of disease activity recurrence. Disease activity was assessed based on Best-Corrected Visual Acuity using the Early Treatment of Diabetic Retinopathy Screening methodology and the central subfield thickness using Spectral-Domain OCT. If criteria were not met throughout Week 52, 365 days were entered. | Full Analysis Set, Study Eye | Posted | Mean | Standard Deviation | Days | From Week 12 through Week 52 |
|
Day 0 up to Week 52
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of OXU-001 with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A1: OXU-001 / Mid Dose | 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. OXU-001: Suprachoroidal sustained release dexamethasone acetate Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | A2: OXU-001 / High Dose | 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. OXU-001: Suprachoroidal sustained release dexamethasone acetate Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device | 0 | 2 | 0 | 2 | 2 | 2 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hemorrhage | Eye disorders | MedDRA (25.1) | Systematic Assessment | Study Eye |
|
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment | Right Humerus Fracture |
|
| Worsening of Diabetes Mellitus | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Worsening of Arterial Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Friedrich Asmus, MD, Chief Medical Officer | Oxular Ltd | 617 882 7179 | friedrich.asmus@ocular-cc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2023 | Aug 14, 2025 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D004487 | Edema |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015785 | Eye Diseases, Hereditary |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Number of Participants with Ocular Serious Adverse Events |
|
| Number of Participants with Systemic (Non-Ocular) Serious Adverse Events |
|
| Number of Participants with Adverse Events of Special Interest |
|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|