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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 9
- 主要终点
- Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Part A is open-label, no masking. Part B is masked for the subject and the outcomes assessing site team and central reading center.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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.
研究组 & 干预措施
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.
干预措施: OXU-001 (Drug)
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.
干预措施: Semi-automated suprachoroidal illuminated microcatheter (Device)
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.
干预措施: OXU-001 (Drug)
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.
干预措施: Semi-automated suprachoroidal illuminated microcatheter (Device)
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.
干预措施: OXU-001 (Drug)
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.
干预措施: Semi-automated suprachoroidal illuminated microcatheter (Device)
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
干预措施: OXU-001 (Drug)
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
干预措施: Semi-automated suprachoroidal illuminated microcatheter (Device)
B3: Ozurdex®
A single treatment with intravitreal Ozurdex®
干预措施: Ozurdex® Ophthalmic Intravitreal Implant (Drug)
结局指标
主要结局
Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
时间窗: 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
时间窗: 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)
次要结局
未报告次要终点