EUCTR2016-002971-91-IT进行中（未招募）1 期
A randomized, double-masked, placebo-controlled exploratorystudy to evaluate safety, tolerability, pharmacodynamics andpharmacokinetics of orally administered BI 1467335 for 12weeks with a 12 week follow up period in patients with nonproliferativediabetic retinopathy without center-involveddiabetic macular edema - ROBIN study
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 100 人开始时间: 2018年2月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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. Of full age (according to local legislation, usually = 18 years) and = 80
- •years at screening
- •2. Male or female patients. Women of childbearing potential (WOCBP)1
- •must be ready and
- •able to use two methods of contraception with at least one of them being
- •effective method of birth control per ICH M3 (R2) that result in a low
- •failure rate of less
- •than 1% per year when used consistently and correctly. A list of
- •contraception methods
- •meeting these criteria is provided in the patient information.
- •3. Diagnosis of diabetes mellitus (type 1 or type 2):
- •- Documented diabetes by American Diabetes Association (ADA) and/or
- •World Health
- •Organization criteria
- •- Antidiabetic medication stable for =3 months prior to screening and
- •expected to be
- •stable throughout the trial (no change in medication or the dose, except
- •for insulin the prescribed total daily dose change not more than 10%)
- •4. Glycosylated hemoglobin (HbA1c) = 10% at screening
- •5. Non-proliferative diabetic retinopathy (NPDR) without center-involved
- •diabetic macular
- •edema (CI-DME) in the study eye at screening with NPDR level 47 or
- •level 53, as
- •determined by the CRC by using the DR severity scale (DRSS)
- •6. Best corrected visual acuity ETDRS letter score = 70 letters in the
- •study eye at screening
- •7. Media clarity, pupillary dilation and individual cooperation sufficient
- •for adequate retinal
- •examination including fundus photographs and OCT
- •8. Signed and dated written informed consent in accordance with ICHGCP
- •legislation prior to admission to the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Additional eye disease in the study eye that, in the opinion of the
- •investigator, could
- •compromise or alter visual acuity during the course of the study (e.g.
- •vein occlusion,
- •uncontrolled intraocular pressure (IOP) >24 mmHg on optimal medical
- •glaucoma with visual field loss, uveitis or other ocular inflammatory
- •vitreomacular traction, monocular vision, history of ischemic optic
- •neuropathy, or genetic
- •disorders such as retinitis pigmentosa)
- •2. Active center-involved DME (CI-DME) on clinical examination and OCT
- •subfield thickness above 300 µm in the study eye, as measured by
- •Optovue OCT
- •3. Anterior segment and vitreous abnormalities in the study eye that
- •would compromise the
- •adequate assessment of the best corrected visual acuity or an adequate
- •examination of the
- •posterior pole
- •4. Evidence of neovascularization on clinical examination including active
- •neovascularization of the iris (small iris tufts are not an exclusion) or
- •neovascularization in the study eye, ruled out by gonioscopy
- •(documented in the last 4
- •weeks before screening or performed at screening)
- •5. Prior pan-retinal photocoagulation (defined as = 100 burns placed
- •previously outside of
- •the posterior pole) in the study eye
- •6. History of DME or DR treatment with macular laser within 3 months
- •prior to screening,
- •or intraocular injections of medication within 6 months prior to
- •screening, and no more
- •than 4 prior intraocular injections in the study eye at any time in the
- •7. Patients treated with Monoamine Oxidase B (MAO-B) inhibitors (see
- •Section 4.2.2.1) at
- •the time or up to 3 months prior to randomization or planned initiation
- •during the trial
- •8. Current or planned, during the trial, use of medications known to be
- •toxic to the retina,
- •lens or optic nerve, or cause vision loss
研究者
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