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). - OXUCT-102

Oxular IE Limited0 个研究点目标入组 128 人开始时间: 2023年5月4日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Oxular IE Limited
入组人数: 128

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Able to understand and sign an informed consent form., At least eighteen (18) years of age at the time of screening., Have been diagnosed with Type 1 or Type 2 diabetes mellitus., Have DME involving the center of the fovea with central subfield thickness (CST) in the study eye at the screening visit, confirmed by the CRC, of at least 320 µm on SD OCT (measurement from the Retinal Pigment Epithelium, RPE, to the Inner Limiting Membrane, ILM, inclusively)., Have BCVA in the study eye between 34 and 78 letters ETDRS (approximate Snellen acuity of 20/200-20/32) at the screening visit. For eligibility assessments, only the ETDRS BCVA letter score is considered relevant., For women who are not postmenopausal (i.e., at least 12 months of non-therapy-induced amenorrhea or surgically sterile (absence of ovaries and/or uterus)) agreement to remain abstinent or use combined contraceptive methods that result in a failure rate of less than 1% per year from the treatment visit (Visit 2, Day 0) until the end of trial participation, or, if subjects discontinue trial participation prior to Week 52 completion, for at least 52 weeks from the treatment visit (Visit 2, Day 0). Examples of contraceptive methods with an expected failure rate of less than 1% per year include male sterilization, hormonal implants, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of less than 1% per year. Barrier methods must always be supplemented with the use of a spermicide., Males must agree to use a barrier method of contraception starting from the treatment visit (Visit 2, Day 0) until the end of trial participation, or, if subjects discontinue trial participation prior to Week 52 completion, for at least 52 weeks from the treatment visit (Visit 2, Day 0)., Subject must be willing not to participate in any other clinical trial including an investigational medicinal product (IMP) or an investigational device until the end of trial participation.

排除标准

•Presence of any significant ocular or non-ocular disease/disorder (or medication and/or laboratory test abnormalities) which, in the opinion of the Investigator and with the concurrence of the Oxular Medical Monitor, may 1.put the subject at risk because of participation in the trial, or 2.influence the results of the trial, or 3.influence the subject’s ability to participate in the trial, or 4.may require medical or surgical intervention during study participation (e.g., cataract, vitreous hemorrhage, retinal detachment, or macular hole)., History of closed-angle glaucoma., IOP <6mmHg (hypotony) in the study eye at screening., Spherical equivalent of the refractive error of -6 diopters of myopia or worse (prior to cataract or refractive surgery) at screening., Cataract or other media opacity that limits the ability to obtain the planned imaging assessments., History of retinal detachment., Prior treatment with IVT anti-VEGF in the study eye 1.Treatment naïve group (Part B): Any IVT anti-VEGF treatments in the study eye are exclusionary regardless of the time interval since injection. 2.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: a)Subject has received less than three (3) anti-VEGF injections since treatment initiation (at least three injections must have been received for eligibility). b)Time interval between the first anti-VEGF injection and screening is more than forty (>40) weeks. c)Last injection with ranibizumab or bevacizumab within four (4) weeks prior to screening. d)Last injection with aflibercept within eight (8) weeks prior to screening. e)Last injection with faricimab or brolucizumab within twelve (12) weeks prior to screening. f)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 (Part A and B). A history of topical ocular steroids is not exclusionary., Prior ocular treatment with steroid injections (periocular, subtenon, intravitreal) or intravitreal implants in the fellow eye (Part A) (due to potential interference with PK measurements). 1.Last injection (intra- or periocular/subtenon) with triamcinolone acetonide within 12 weeks before screening. 2.Last injection (suprachoroidal) steroids, e.g., Xipere™, within twelve (12) weeks before screening. 3.Last injection (IVT) with dexamethasone implant (Ozurdex®) within 24 weeks before screening. 4.Prior treatment with longer duration implants (e.g., fluocinolone acetonide IVT implant, Iluvien) is exclusionary., Prior treatment with suprachoroidal steroids in the study eye is exclusionary., Concurrent use of systemic glucocorticoid medications or systemic steroids within twelve (12) weeks before screening is exclusionary. Intranasal, inhaled, and extra-ocular topical corticosteroids are allowed., Macular edema considered due to a cause other than diabetes mellitus in either eye., Prior IVT or suprachoroidal treatment with investigational agents in either eye (e.g., agents with anti-VEGF activity, or combined pharmacologic activity, gene therapies, cell therapies, or any other therapeutic modality) at any time., Participation in a clinical trial in which an investigational drug (with other routes of administration than IVT or suprachoroidal) was administered within 90 days of screening or 5

研究者

发起方

Oxular IE Limited

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