A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study) (iDEAL)
2017年7月28日 更新者：Johns Hopkins University
A Randomized, Multi-center, Phase II Study of the Safety, Tolerability, and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema With Involvement of the FoveAL Center (the iDEAL Study)
- To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation
- To assess the change in visual acuity and retinal thickness on optical coherence tomography (OCT) from baseline to month 8 and month 12
研究概览
地位
终止
条件
研究类型
介入性
注册 (实际的)
185
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Nebraska
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Omaha、Nebraska、美国、68198-5540
- Stanley M Truhlsen Eye Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age ≥18 years
- Have diabetes mellitus type I or II (insulin or non-insulin dependent) with HbA1c ≥5.5% and HbA1c ≤13%; have non-proliferative diabetic retinopathy, or inactive proliferative diabetic retinopathy, or proliferative diabetic retinopathy with a reasonable expectation that panretinal photocoagulation will not be required during the study follow-up period
- Have diabetic macular edema with central subfield thickness of ≥250 microns (confirmed by Stratus Time-Domain(TD) OCT
Have best corrected visual acuity (ETDRS) that is Snellen equivalent of
- 20/32 and ≥20/320, inclusive
- Be willing and able to sign an approved written informed consent. If a patient has a central nervous system disorder (i.e. dementia) that will not allow him/her to understand the consent independently, the patient will not be allowed to join the study
- Be able to attend all scheduled study visits
- Women who are not lactating or pregnant and are willing to use adequate contraception during the study period, if appropriate
Exclusion Criteria:
- Have macular or perimacular edema secondary to an etiology other than diabetes
- Have concurrent retinal diseases other than diabetic retinopathy
- Have additional ocular diseases compromising visual acuity and/or interfering with study assessments; patients who have glaucoma but deemed stable (intraocular pressure ≤ 25 mmHg at screening) on medications or status post surgery, may participate in the study
- Participant has a history of prior pars plana vitrectomy
- Subjects with significant cataract or or posterior capsular opacification that may need intervention within one year or vitreous opacity that hinder study assessment (i.e.fundus examination) which requires intervention within a year
- Subjects who have DME with severe capillary non-perfusion (avascular zone diameter >1,000 microns)
- Have an allergy to fluorescein dye
- Have terminal renal disease (on active kidney dialysis), cerebral vascular accident(including TIA), myocardial infarction or congestive heart disease within 6 months of study enrollment, liver damage (2x upper limit of normal range for aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or total bilirubin). Patients who may have received renal transplant in the past and now have stable renal function, may participate in the study
- Subjects with systolic blood pressure higher than 180 mm Hg or diastolic above 100 mm Hg, with or without anti-hypertensive treatment
- Have a history of panretinal photocoagulation (PRP) in the study eye within 3 months of study entry or are likely to have PRP in the study eye during study participation
- Had macular photocoagulation or ocular surgery within 3 months of study entry in the study eye
- Received intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry or anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, VEGF-TRAP, protein kinase C inhibitor, etc.) within 2 months of study entry; history of usage of topical or systemic steroids within 3 months of study entry is not an exclusion
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group 1
Drug: iCo-007 350 mcg iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4 |
iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
其他名称：
|
|
实验性的：Group 2
Drug: iCo-007 700 mcg iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4 |
iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
其他名称：
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实验性的：Group 3
Drug: iCo-007 350 mcg and Laser iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation |
iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation.
At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment.
If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
其他名称：
|
|
实验性的：Group 4
Drug: Ranibizumab and iCo-007 350 mcg Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later |
Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in VA From Baseline to Month 8
大体时间：Baseline to month 8
|
The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8
|
Baseline to month 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability
大体时间：Baseline to month 8
|
Safety of repeated iCo-007 intravitreal injections in treatment of subjects with Diabetic Macular Edema (DME) as monotherapy and in combination with ranibizumab or laser photocoagulation.
Serious consideration will be given if 2 or more patients in a particular treatment arm experience the same drug-related serious adverse event;
|
Baseline to month 8
|
|
Change in VA From Baseline to Month 12
大体时间：Baseline to month 12
|
The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 12
|
Baseline to month 12
|
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Change in Retinal Thickness Measured by OCT From Baseline to Month 8
大体时间：Baseline to month 8
|
Group 1
|
Baseline to month 8
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Change in Retinal Thickness Measured
大体时间：Baseline to month 12
|
measured by OCT
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Baseline to month 12
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Duration of iCo-007 Treatment Effect
大体时间：Baseline to month 12
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treatment effect as measured by VA and OCY thickness
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Baseline to month 12
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Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections
大体时间：Baseline to month 12
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cmax
|
Baseline to month 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Diana V. Do, MD、Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center
- 首席研究员：Robert Wong, MD、Austin Retina Associates
- 首席研究员：Michael J. Tolentino, MD、Center for Retina Macula Disease
- 首席研究员：Prema Abraham, MD、Black Hills Regional Eye Institute
- 首席研究员：Eugene Lit, MD、East Bay Retina Institute
- 首席研究员：Michael J. Elman, MD、Elman Retina Group
- 首席研究员：Thomas A. Barnard, MD、Florida Retina Institute
- 首席研究员：Thomas A. Ciulla, MD、Midwest Eye Institute
- 首席研究员：Richard B. Rosen, MD、New York Eye and Ear Infirmary
- 首席研究员：Henry L. Hudson, MD、Retina Centers, P.C.
- 首席研究员：Pravin Dugel, MD、Retina Consultants of Arizona
- 首席研究员：Gregg T. Kokame, MD、Retina Consultants of Hawaii, Pali Momi Medical Center
- 首席研究员：David M. Brown, MD、Retina Consultants Houston
- 首席研究员：Larry S. Halperin, MD、Retina Group of Florida
- 首席研究员：Goergios Papastergio, MD、Retina Institute of Hawaii
- 首席研究员：Ron P. Gallemore, MD. PhD、Retina Macula Institute
- 首席研究员：Brian B. Berger, MD、Retina Research Center
- 首席研究员：Homayoun Tabandeh, MD、Retina Vitreous Associates
- 首席研究员：Dennis M. Marcus, MD、Southeast Retina
- 首席研究员：Robert S. Wirthlin, MD、Spokane Eye Clinic
- 首席研究员：David Callanan, MD、Texas Retina Associates in Arlington
- 首席研究员：Karl G. Csaky, MD, PhD、Texas Retina Associates in Dallas
- 首席研究员：Surendar Purohit, MD、TLC Eye Care & Laser Center
- 首席研究员：Victor H. Gonzalez, MD、Valley Retina Institute
- 首席研究员：Louis Glazer, MD、Vitreo-Retinal Associates
- 首席研究员：Dean Eliott, MD、Massachusetts Eye and Ear Infirmary, Harvard Medical School
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年2月1日
初级完成 (实际的)
2014年2月1日
研究完成 (实际的)
2014年10月1日
研究注册日期
首次提交
2012年3月15日
首先提交符合 QC 标准的
2012年3月26日
首次发布 (估计)
2012年3月28日
研究记录更新
最后更新发布 (实际的)
2017年8月30日
上次提交的符合 QC 标准的更新
2017年7月28日
最后验证
2017年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.