NCT01565148终止2 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Change in VA From Baseline to Month 8
研究概览
简要总结
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1
Experimental
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
干预措施: iCo-007 350 mcg (Drug)
Group 2
Experimental
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
干预措施: iCo-007 700 mcg (Drug)
Group 3
Experimental
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
干预措施: iCo-007 350 mcg and Laser (Drug)
Group 4
Experimental
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
干预措施: Ranibizumab and iCo-007 350 mcg (Drug)
结局指标
主要结局
Change in VA From Baseline to Month 8
时间窗: 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
次要结局
- Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability(Baseline to month 8)
- Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections(Baseline to month 12)
- Change in Retinal Thickness Measured by OCT From Baseline to Month 8(Baseline to month 8)
- Change in Retinal Thickness Measured(Baseline to month 12)
- Duration of iCo-007 Treatment Effect(Baseline to month 12)
- Change in VA From Baseline to Month 12(Baseline to month 12)
研究者
研究点 (1)
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