CTRI/2017/01/007630尚未招募4 期
Correlation between aqueous VEGF levels and clinical treatment response in ranibizumab treated DME- Identifying and characterizing responders and nonresponders
Dr Gopal S Pillai0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 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
入排标准
入选标准
- •1)Male or female patients >18 years of age who have signed an informed consent
- •2)Type II DM with centre involving DME
- •3)Best corrected Visual acuity (BCVA) 20/30 to 20/200 (6/9 to 6/60 Snellen )
- •4)Central Macular thickness more than 300 microns
- •5)Medication for the management of diabetes must have been stable within 3 months prior to screening and is expected to remain stable during the course of the study.
排除标准
- •1)Exclusion criteria will comply with local label
- •2)Other progressive retinal diseases
- •3)Active intraocular inflammation (grade trace or above) in either eye or any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
- •4)Media opacities which prevents good documentation
- •5)Uncontrolled glaucoma in either eye (e.g. IOP > 24 mmHg on medications, or according to investigatorââ?¬•s judgement)
- •6)Neovascularization of the iris in either eye
- •7)Evidence of vitreomacular traction in either eye
- •8)Previous vitrectomy
- •9)Recent cataract surgery within 3 months or Pan-retinal laser photocoagulation in the study eye within 6 months or Focal/grid laser photocoagulation in the study eye within 3 months prior to screening
- •10)Recent intravitreal injection within 3 months (e.g. - pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, corticosteroids etc.)
- •11)History of stroke , heart attack or any other thrombo embolic event within the last 6 months.
- •12)Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels > 2.0 mg/dl
- •13)Untreated diabetes mellitus
- •14)Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg and Untreated or uncontrolled hypertension
- •15)Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol
- •16) Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation or fluorescein
- •17)Any type of advanced, severe or unstable disease or its treatment, that could interfere with primary and/or secondary outcome evaluations
- •18)Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to randomization
- •19)Inability to comply with study or follow-up procedures.
- •20)Pregnant or nursing (lactating) women
- •21)Any type of systemic disease or its treatment, including any medical condition (controlledor uncontrolled) that could be expected to progress, recur, or change to such an extent thatit may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk
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