EUCTR2013-003147-27-HU进行中（未招募）不适用
A PHASE 2, RANDOMIZED, DOUBLE-MASKED, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO COMPARE THE EFFICACY AND SAFETY OF A CHEMOKINE CCR2/5 RECEPTOR ANTAGONIST (PF-04634817) WITH THAT OF RANIBIZUMAB IN ADULT SUBJECTS WITH DIABETIC MACULAR EDEMA
Pfizer Inc 235 East 42nd Street, New York, NY 10017 US0 个研究点目标入组 200 人开始时间: 2013年11月4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
- 入组人数
- 200
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. Evidence of a personally signed and dated informed consent document
- •indicating that the subject (or a legal representative) has been informed
- •of all pertinent aspects of the study.
- •2. Subjects who are willing and able to comply with scheduled visits,
- •treatment plan, laboratory tests, and other study procedures.
- •3. Female subjects of non-childbearing potential =18 years and male
- •subjects =18 years. A subject is of childbearing potential if, in the
- •opinion of the investigator, he/she is biologically capable of having
- •children and is sexually active.
- •4. Clinical diagnosis of diabetes mellitus (type 1 or type 2).
- •5. Stable medication for the management of diabetes (for those subjects
- •on anti-diabetes medication) for at least 3 months before randomization
- •and expected to remain stable during the study.
- •6. Serum HbA1c =10.5% at the screening visit.
- •7. Diabetic macular edema affecting the fovea in the study eye,
- •consisting of central retinal thickness on OCT measuring 250 µm or more
- •at the screening visit and a diagnosis of DME confirmed by fluorescein
- •angiography.
- •8. Reduced visual acuity resulting from retinal thickening involving the
- •center of the fovea and a BCVA, using ETDRS visual acuity protocol of
- •20/32 or worse (letter score of =78) and up to 20/320 or better (letter
- •score =24) in the study eye at the screening visit.
- •9. Visual acuity score in the non-study eye of 20/400 or better (letter
- •score of =19) at the screening visit.
- •10. Subjects who have not been treated with anti-angiogenic therapy,
- •including pegaptanib sodium, bevacizumab, ranibizumab or aflibercept,
- •or intra/peri-ocular steroids in either
- •eye within 3 months of the screening visit and who, from a clinical
- •perspective, are considered suitable for the withholding of treatment for
- •diabetic macular edema, including laser photocoagulation, for the
- •duration of the study following enrolment (at least 90 days).
- •11. Ocular media and adequate pupillary dilation to allow good quality
- •OCT and fundus photography.
- •12. If both eyes meet the inclusion criteria for this study, the most
- •severely affected eye will become the study eye. If both eyes are
- •affected equally, then the investigator and the
- •subject will select the study eye.
- •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 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects (subs) who are investigational site staff members directly
- •involved in the conduct of the trial and their family members, site staff
- •members otherwise supervised by the Investigator, or subs who are
- •Pfizer employees directly involved in the conduct of the trial.
- •2. Participation in other studies involving investigational drug(s) (Ph. 1-4)
- •during study participation or within the prev. 60 days or 5 half-lives
- •preceding the 1st dose of study medication whichever is longer. 3. Other
- •severe acute or chronic med or psychiatric condition or lab abnormality
- •that may incr the risk associated with study participation or
- •investigational product (IP) administration or may interfere with the
- •interpretation of study results and, in the judgment of the investigator,
- •would make the subject inappro. for entry into this study. 4. Females of
- •childbearing potential or who are pregnant or breastfeeding. 5. Males of
- •childbearing potential who are unwilling or unable to use a highly
- •effective method of contraception as outlined in this protocol for the
- •duration of the study and for at least 28 days after the last dose of IP. 6.
- •Known history of HIV based on documented history with + serological
- •test, or + HIV serological test at screening. 7. Any history of prev.
- •untreated or current evidence of active or untreated latent infection with
- •Mycobacterium tuberculosis (TB). 8. Family history of prolonged QT
- •syndrome, or who themselves have a QTC >450 msec for males or >470
- •msec for females, a QRS >120 msec, or PR interval =300 msec, whether
- •considered clinically significant or not, should not be incl. in study. Any
- •clinically-significant ischemic changes as assessed by the investigator by
- •12-lead ECG at screening. The ECG should be repeated two more times
- •and the av. of 3 QTc, QRS or PR values should be used to determine the
- •subject's eligibility. QT should be corrected using Fridericia's correction.
- •9. Severely impaired renal function as defined by an eGFR of <30
- •mL/min/1.73m2 calculated using the CKDEPI eqn. at screening. 10. Any
- •relevant, clinically-significant abnormalities on physical examination or
- •clinically-significant lab tests, including subs with mod. liver function
- •test abnormalities >1.5 times the upper limit of normal. 11. Pan retinal
- •photocoagulation or macular photocoagulation performed in either eye
- •within 3 mo. of the screening visit. 12. Any intraocular condition or prev.
- •surgery in either eye that, in the opinion of the investigator, would
- •either (a) likely require medical or surgical intervention during the 16
- •wk duration of the study to prevent or treat visual loss that might result
- •from that condition, or (b) if allowed to progress untreated, would likely
- •contribute to loss of at least 2 ETDRS lines of BCVA over a 16 wk period,
- •or (c) may affect macular edema or reduce visual acuity during the
- •course of the study. 13. Ocular or peri-ocular infection in the study eye.
- •14. Cataract surgery in either eye within 60 days prior to study
- •enrolment. 15. High risk proliferative diabetic retinopathy (PDR) in
- •either eye. Inactive fibrosed neovascularization following pan retinal
- •photocoagulation (PRP) laser therapy and non high risk PDR with no
- •evidence of vitreous hemorrhage is permitted. 16. Structural damage to
- •the center of the macula in either eye likely to preclude improvement in
- •visual acuity following the resolution of macular edema, including but
- •not limited to persistent DME involving the foveal center of more than 2
研究者
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