EUCTR2021-006765-38-ES进行中（未招募）1 期
A Multi-Center, Open-label, 24-week Clinical Investigation to Evaluate Safety and Tolerability of Treatment with the Oxulumis®, Suprachoroidal Drug Administration Device,Delivering 2.4mg Triamcinolone Acetonide (Triesence®) in Participants with Diabetic Macular Edema (OXUCT-101) - OXUCT-101
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Oxular Ltd.
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Able to understand and sign an informed consent form.
- •2.At least 18 years of age at the time of screening.
- •3.Have been diagnosed with Type 1 or Type 2 diabetes mellitus.
- •4.Have DME involving the center of the fovea in the study eye with a CRT, at the screening visit, of:•= 320 for males or = 305 for females on Spectralis (Heidelberg) or •= 305 for males or = 290 for females with Cirrus (Zeiss) by SD-OCT.
- •5.Have BCVA in the study eye between 34 and 68 letters ETDRS (approximate Snellen acuity of 20/200–20/50*) at the screening visit.
- •6.Have shown limited response to previous IVT treatment with anti-VEGF agents or local corticosteroid treatment (IVT, subtenon, topical) defined as less than 20% reduction of CST with previous treatments
- •7.Study eye suitable for suprachoroidal injection in the judgment of the investigator in agreement with the medical monitor. Patients with ocular hypotony, or structural abnormalities like choroidal coloboma, or chorioretinal anastimosis, amongst others, are not eligible.
- •* For eligibility assessments, only the ETDRS BCVA measurement is considered relevant.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Presence of any other ocular condition in the study eye such that, in the opinion of the investigator, visual acuity may not improve from the resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, or nonretinal causes).
- •2.Active proliferative diabetic retinopathy (PDR) or sequelae of PDR(including iris neovascularization, vitreous hemorrhage, or tractional retinal detachment) at screening in the study eye.
- •3.Pan-retinal photocoagulation (PRP) or macular laser photocoagulation in the study eye performed within sixteen (16)weeks before screening.
- •4.Prior IVT treatment with anti-VEGF in the study eye:
- •a.Last injection with ranibizumab or bevacizumab within four (4) weeks before screening.
- •b.Last injection with aflibercept or brolucizumab within eight (8) weeks before screening.
- •c.Last injection with faricimab within twelve (12) weeks before screening.
- •5.Prior ocular treatment with steroids in the study eye:
- •a.Last injection (intra or periocular) with TA within three (3) months before screening.
- •b.Last injection (IVT) with dexamethasone implant (Ozurdex®) within six (6) months before screening.
- •c.Prior treatment with longer duration implants (e.g., fluocinolone acetonideIVT implant, Iluvien®) is not allowed.
- •d.Prior treatment with suprachoroidal steroids is not allowed.
- •6.Concurrent use of systemic glucocorticoid medications or systemic steroids within twelve (12) weeks before screening. Intranasal, inhaled, and topical corticosteroids are allowed.
- •7.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 medicinal product, at any time).
- •8.History of vitreoretinal surgery (including surgery for retinal detachment or scleralbuckle) in the study eye.
- •9.Treatment with ocriplasmin (Jetrea®), in the study eye, at any time.
- •10.History of retinal detachment in the study eye.
- •11.IOP = 22 mmHg, uncontrolled ocular hypertension, or glaucoma (open-angle) in the study eye, treated with more than two (2) topical hypotensive medication.
- •12.IOP <6mmHg (hypotony) in the study eye.
- •13.History of closed-angle glaucoma in the study eye.
- •14.Spherical equivalent of the refractive error of -6diopters of myopia or worse (before cataract or refractive surgery) at screening in the study eye.
- •15.Any other previous ophthalmic surgeries, uncomplicated cataract surgery, or trauma in the study eye within twelve (12) weeks before screening.
- •16.Visually significant cataract in the study eye at screening.
- •17.Inability to obtain planned imaging assessments due to media opacity, allergy to fluorescein, or any other reasons in the study eye.
- •18.History of recurrent or active intraocular inflammation/infection in either eye (e.g., uveitis).
- •19.Infectious eye disease like infectious blepharitis, keratitis, scleritis, or conjunctivitisin either eye within four (4) weeks of screening.
- •20.Active malignancy or history of malignancy within the past five(5) years.
- •21.Persons who are pregnant or breastfeeding at the screening visit, or who test positive for pregnancy at the screening visit or areunwilling to use adequate birth control methods to prevent pregnancy throughout the study.
- •22.History ofother diseases, metabolic dysfunction, physical examination, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational
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