EUCTR2017-001172-36-DK进行中（未招募）1 期
Efficacy and safety of dexamethasone nanoparticles eye drops in diabetic macular edema.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Oculis ehf.
- 入组人数
- 144
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
入选标准
- •Subjects must:
- •a)Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central macular thickness, CMT, of = 310µm by SD-OCT at baseline (Visit 2) (as measured by the Investigator and confirmed by the Reading Center)
- •b)Have definite retinal thickening in the study eye due to DME involving the central macula based on the Investigator’s clinical evaluation and by SD-OCT; Note: If the DME consists of circumscribed, focal leakage that the evaluating Investigator believes should be treated with laser and no other treatments, the eye is not eligible to be a study eye.
- •c)Have an ETDRS BCVA letter score = 73 (Snellen 20/40) and = 24 (Snellen 20/320) in the study eye at baseline (Visit 2)
- •d)Have a documented diagnosis of type 1 or type 2 diabetes mellitus and a glycosylated hemoglobin A1c (HbA1c) of = 12.0% at Visit 1
- •e)Have a negative urine pregnancy test at Visit 1, if female of childbearing potential those who have experienced menarche and who are not surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral oophorectomy] or post-menopausal [12 months after last menses]) and must use adequate birth control throughout the study period. Adequate birth control is defined as hormonal – oral, implantable, injectable, or transdermal contraceptives; mechanical – spermicide in conjunction with a barrier such as condom or diaphragm; intrauterine device (IUD); or surgical sterilization of partner. For non- sexually active females, abstinence may be regarded as an adequate method of birth control;
- •f)Agree to not participate in another interventional study after providing informed consent and until the study is completed
- •g)Provide written informed consent prior to any study procedure being performed and be able and willing to follow all instructions and attend all study visits
- •h)Be 18-85 years of age at screening (Visit 1), of either sex and any race or ethnicity
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 69
排除标准
- •Subjects must not:
- •a)Have macular edema considered to be due to a cause other than DME; Note: an eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction;(2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema, or (3) the macular edema is considered to be related to another condition such as age-related macular degeneration, uveitis, retinal vein occlusion, or drug toxicity
- •b)Have a decrease in BCVA due to causes other than DME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, non-retinal condition, substantial cataract, macular ischemia) that is likely to be decreasing BCVA by three lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal)
- •c)Have significant macular ischemia.
- •d)Have any other ocular disease that may cause substantial reduction in BCVA, including, retinal detachment, epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases
- •e)Have active peri-ocular or ocular infection (e.g., blepharitis, keratitis, scleritis, or conjunctivitis)
- •f)Have a history of non-infectious uveitis
- •g)Have high myopia (-8 diopter or more correction)
- •h)Must NOT wear contact lenses during the 12 week active treatment study period
- •i)Have a history of any ocular surgery within 3 months prior to Visit 1
- •j)Have a history of YAG laser capsulotomy within 3 months prior to Visit 1;
- •k)Have a history of panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Visit 1 or an anticipated need for PRP during the course of the study
- •l)Have a history of prior IVT, subtenon, or periocular, non-sustained release, steroid therapy within 3 months prior to Visit 1 (e.g., triamcinolone)
- •m)Have a history of intravitreal sustained release dexamethasone therapy within six months prior to Visit 1
- •n)Have a history of intravitreal sustained release fluocinolone within three years prior to Visit 1
- •o)Have a history of prior treatment of intravitreal (IVT) aflibercept within 8 weeks and ranibizumab/bevacizumab within 6 weeks of Visit 1
- •p)Have a history of prior treatment for DME with any other (than previously listed) approved treatment which is not labeled for DME within one year prior to Visit 1
- •q)Have high-risk proliferative diabetic retinopathy (PDR), defined in the ETDRS study as at least one of the following:
- •New vessels within one disc diameter of the optic disc (NVD) = 1/3 disc area;
- •Any NVD with vitreous or pre-retinal hemorrhage;
- •New vessels elsewhere in the retina (NVE) = ½ disc area and pre-retinal or vitreous hemorrhage;
- •r)Have uncontrolled ocular hypertension or glaucoma in either eye, defined as intraocular pressure (IOP) = 22 mmHg on more than 1 IOP lowering medications at Visit 1
- •s)Have poor media clarity, pupillary constriction (i.e., se
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