EUCTR2018-004785-33-ES进行中（未招募）1 期
A 12-month, Prospective, Open-label, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Treatment Naïve Patients (according to standard clinical practice) with Diabetic Macular Edema - EYEberia
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •1.Male or female = 18 years of age
- •2.Prior diagnosis of diabetes mellitus (type 1 or type 2)
- •3.Presence of macular edema associated with diabetic retinopathy defined as macular thickening by optical coherence tomography (OCT) assessed by the investigator with the following characteristics:
- •3.1.Involving the center of the macula (fovea)
- •3.2.Visual acuity (VA) decrease attributable to macular edema
- •4.Patients who are treatment naïve prior to enrollment in this study but have been prescribed OZURDEX by a physician. The prescribing information is at the discretion of the physician and reflects their standard of practice
- •5.BCVA score between 20 and 70 letters (approximately 20/40 to 20/400 on the Snellen scale) using the Early Treatment Diabetic Retinopathy Study (ETDRS) method at the Baseline visit
- •6.Media clarity, pupillary dilation, and patient cooperation sufficient for all study procedures
- •7.Women of childbearing potential should have a negative urine pregnancy test at the Baseline visit
- •8.Written informed consent obtained in accordance with all local privacy requirements
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Investigators must refer to the Summary of Product Characteristics (SPC) for information on contraindications (Section 4.3), Warnings (Section 4.4), and Pregnancy and Lactation (Section 4.6).
- •1.Uncontrolled systemic disease
- •2.History of disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of the investigational drug, might affect the interpretation of study results, or render the patient at high risk from treatment complications
- •3.Patients who have been previously treated for DME (use of two focal laser allowed)
- •4.Presence of vitreomacular traction or pathology of epiretinal membrane that, in the opinion of the investigator, may significantly interfere with functional response to treatment
- •5.Presence of anatomic biomarkers in OCT (disorganization of the retinal inner layers, damage of the ellipsoid zone) and OCT angiography (macular ischemia) that, in the opinion of the investigator, may significantly interfere with functional response to treatment
- •6.Use of systemic corticosteroids within 1 month prior to Screening
- •7.Untreated diabetes or anticipated change (increase) of antidiabetic medications during the study
- •8.Elevated IOP or glaucoma diagnosis
- •9.A substantial cataract is present that in the opinion of the investigator will need cataract surgery during the study and/or will not allow to perform imaging tests. ( If the patients is pseudophakic, cataract surgery was performed at least 3 months before recruitment in this study.
- •10.Anticipated need for ocular surgery during the study
- •11.History of vitrectomy or incisional glaucoma surgery
- •12.Use of any intravenous steroid or intravitreal triamcinolone prior to Screening
- •13.Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
- •14.Any condition that, in the opinion of the investigator, may interfere with follow up visits
- •15.Known allergy, hypersensitivity or contraindication to the study medication, its components, or povidone iodine
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