EUCTR2014-001639-35-DE进行中（未招募）1 期
A randomized, single-blinded, multicenter, phase IV study to compare systemic VEGF protein dynamics following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept until study week 12 in patients with visual impairment due to diabetic macular edema - TIDE DME
ovartis Pharma GmbH0 个研究点目标入组 40 人开始时间: 2014年7月8日最近更新:
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
- 入组人数
- 40
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
- •Inclusion criteria for patient:
- •1. Male or female patients, = 18 years of age.
- •2. Written informed consent must be obtained before any study-related assessment is performed.
- •Inclusion criteria for study eye:
- •3. Type 1 or Type 2 diabetes mellitus according to ADA (2014) and/or WHO (2006) classifications (see Appendix 2, Table A2-2) with glycosylated hemoglobin (HbA1c) = 10% (= 86 mmol/mol) at screening. Patients should be on diet, exercise and/or pharmacological treatment for diabetes, which must have been stable for at least 3 months.
- •4. Visual impairment predominantly due to DME.
- •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 20
排除标准
- •Exclusion criteria for systemic medical history and conditions:
- •1. Any type of systemic disease or its treatment, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
- •2. Stroke or myocardial infarction less than 3 months prior to screening.
- •3. Presence of uncontrolled systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at the time of screening or baseline.
- •4. Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels >2.0 mg/dl at screening.
- •5. Untreated diabetes mellitus
- •6. Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures or to fluorescein or any other component of fluorescein formulation.
- •Exclusion criteria for ocular medical history and conditions:
- •For either eye:
- •7. Any active periocular or ocular infection or inflammation at the time of screening or baseline
- •8. Uncontrolled glaucoma (intraocular pressure [IOP] =30 mm Hg on medication or according to investigator’s judgment) at the time of screening or baseline.
- •9. Neovascularization of the iris or neovascular glaucoma at the time of screening or baseline.
- •For study eye:
- •10. Atrophy or fibrosis involving the center of the fovea at the time of screening or baseline.
- •11. Cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization or macular edema of any other cause than DME at the time of screening or baseline.
- •12. Irreversible structural damage within 0.5 disc diameter of the center of the macula (e.g., vitreomacular traction, epiretinal membrane, scar, laser burn, macular hole) at the time of screening or baseline that in the investigator’s opinion could preclude visual function improvement with treatment.
- •For fellow eye:
- •13. Retinal or choroidal neovascularization or macula edema of any cause at the time of screening or baseline or the anticipation of development of the above mentioned medical conditions within 3 months past screening or baseline.
- •Exclusion criteria for prior or current systemic medication:
- •14. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives from screening, whichever is longer.
- •15. Use of any systemic anti-VEGF drugs (e.g., bevacizumab [Avastin®], ziv-aflibercept [Zaltrap®]).
- •16. Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening.
- •17. Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine (Plaquenil®), tamoxifen, phenothiazines and ethambutol.
- •Exclusion criteria for prior or current ocular treatment:
- •For study eye:
- •18. Panretinal laser photocoagulation within 6 months prior to randomization.
- •19. Focal/grid laser photocoagulation within 3 months prior to randomization.
- •20. Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following baseline.
- •21. Topical ocular corticosteroids administered for at least 30
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