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)
Overview
- Phase
- Phase 2
- Intervention
- OXU-001
- Conditions
- Diabetic Macular Edema
- Sponsor
- Oxular Limited
- Enrollment
- 3
- Locations
- 9
- Primary Endpoint
- Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief 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 (OZURDEX®) in subjects with diabetic macular edema.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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:
- •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.
Arms & Interventions
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.
Intervention: OXU-001
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.
Intervention: Semi-automated suprachoroidal illuminated microcatheter
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.
Intervention: OXU-001
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.
Intervention: Semi-automated suprachoroidal illuminated microcatheter
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.
Intervention: OXU-001
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.
Intervention: Semi-automated suprachoroidal illuminated microcatheter
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
Intervention: OXU-001
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
Intervention: Semi-automated suprachoroidal illuminated microcatheter
B3: Ozurdex®
A single treatment with intravitreal Ozurdex®
Intervention: Ozurdex® Ophthalmic Intravitreal Implant
Outcomes
Primary Outcomes
Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Time Frame: Day 0 up to Week 52
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)
Frequency and Severity of Treatment-emergent Adverse Device Effects
Time Frame: Day 0 up to Week 52
Treatment-emergent adverse device effects are defined as effects emerging following administration of study treatment at Visit 2 (Baseline, Day 0)