EUCTR2007-006795-10-GB进行中（未招募）不适用
A randomised controlled trial of efficacy of Pegaptanib sodium in the prevention of proliferative diabetic retinopathy - EPPPDR
Frimley Park Hospital NHS Foundation Trust0 个研究点开始时间: 2008年7月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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)TypeI or Type II Diabetes
- •2)Serum HbA1C >5.5% and <12% at screening visit
- •3)ETDRS 53 A_E. 61,65
- •4)BCVA letter score in study eye < 80 using an ETDRS chart measured at 4 meters distance
- •5)BCVA letter score in fellow eye of >19 letters
- •6)Male or female patients at least 18 years of age. Female subjects either of non child bearing potenial (hysterectomised or believed to be post menopausal as evidenced by a three yera history of amenorrhoea) or of cild bearing age are eligible, provided they have a negative urinary pregnancy test at the screening and baseline visit. Female subjects of child bearing potential should be willing to use adequate (atleast to forms of) contraceptive methods as described below during the treatment period and for three months after the last dose of study medication. Male subjects with partners of child bearing potential must agree to use adequate (at least one form of) contaception as described below during the treatment period and for three months after the last dose of study medication or be surgically sterile.
- •Acceptable contraceptive methods for female (need at least two)
- •Hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone- releasing IUDs) at least 14 days prior to the first dose of trial medication
- •Abstinence
- •Placement of a copper containing device
- •Condom with spermicidal foam / gel film/ cream/ suppository
- •Tubal ligation
- •Male partner who has had a vasectomy for at least 4 months
- •Acceptable contraceptive methods for male (need at least one)
- •Abstinence
- •Use of condoms for males with a vasectomy
- •Without a vasectomy, must use a condom and be instructed that their female partner should use another form of contraception such as IUD, spermicidal foam/ gel/cream/suppository, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or tubal ligation if the female partner could become pregnant from the first dose of medication until three months after the last dose.
- •7) Patients who provide written and informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Active intraocular or periocular inflammation
- •2) History of intraocular surgeries within the last 2 months in the study eye
- •3) Current treatment with any other investigational product
- •4) Retinal vascular diseases
- •5) Uncontrolled glaucoma (With antiglaucoma medications intraocular pressure more than 30 mmof Hg and or advanced disc cupping with glaucomatous field loss)
- •6) Planned or anticipated need for cataract surgery during the 12month study period
- •7) Pregnant or lactating women
- •8) Other retinal diseases that might affect the outcome (except diabetic maculopathy)
- •Allergy to FFA
- •Allergy to Iodine
- •Inability to obtain colours, fluorescein angiography of sufficient quality.
- •Allergy to anti VEGF medications.
- •Allergy to humanised monoclonal antibody.
- •Inability to comply with follow up procedures
研究者
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