NCT00886808已完成1 期
A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of iCo-007 Intravitreal Injection in Subjects With Diffuse Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Safety and tolerability of 4 dose levels of intravitreal administration of iCo-007.
研究概览
简要总结
The goal of the study is to evaluate the safety and tolerability of 4 different doses of iCo-007 Intravitreal Injection in patients with diffuse diabetic macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Men or women 18 years of age or older
- •Confirmed diagnosis of diabetes mellitus type I or II (both, insulin or non-insulin dependent)
- •Subjects who have moderate to severe non-proliferative diabetic retinopathy (NPDR), as defined by ETDRS criteria, and diffuse DME within 300 microns from the center of the macula in the study eye (with or without cystoid changes) confirmed by FA.
- •Retinal thickness must be at least 250 microns in the central subfield, as shown by OCT
- •Best-corrected visual acuity between 60 and 15 letters measured with ETDRS charts (approximately 20/63 to 20/500 with Snellen charts)
- •Woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening (serum). Both men and women are required to practice an adequate method of birth control
- •Able and willing to sign an approved informed consent form and return for all scheduled study visits
排除标准
- •Subjects with macular or perimacular edema secondary to an etiology other than diabetes mellitus
- •Subjects with concurrent retinal diseases or conditions in the study eye (including conditions requiring urgent PRP), glaucoma (or ocular hypertension), retinal vascular occlusion, exudative age-related macular degeneration (drusen permitted), tear (rip) of the retinal pigment epithelium, a vitelliform-like lesion of the outer retina (e.g. pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis or retinal-lesion anastomosis
- •Subjects who have any additional ocular disease or condition which could compromise treatment safety, visual acuity or interfere with assessment of the macular edema, such as ocular inflammation, amblyopia, anterior ischemic optic neuropathy, media opacity, cataract
- •Subjects who have diffuse DME with severe capillary non-perfusion (avascular zone diameter >1,000 microns)
- •Allergy to fluorescein dye
- •Subjects who had intraocular surgery, photocoagulation, intravitreal or subfoveal injection, topical or systemic steroids or who received any experimental treatment as part of another clinical trial within the last 3 months of the study start (in case of Anecortave within the last 6 months, any panretinal photocoagulation prior to study start)
- •Subjects with uncontrolled diabetes (glycosylated hemoglobin Hb A1c >12%)
- •Subjects with systolic blood pressure higher than 180 mm Hg or diastolic above 100 mm Hg, with or without anti-hypertensive treatment
- •Subjects with congestive heart disease or any unstable cardiac condition
- •Subjects with clinically significantly impaired renal function (serum creatinine >2.0 mg/dL) and/or moderate to severe hepatic impairment (subjects with >2.5 times the upper limit of the normal range for aspartate transaminase [AST], alanine transaminase [ALT], or total bilirubin)
研究组 & 干预措施
1
Experimental
110 microgram dose of iCo-007 Intravitreal Injection
干预措施: iCo-007 Intravitreal Injection (Drug)
2
Experimental
350microgram dose of iCo-007 Intravitreal Injection
干预措施: iCo-007 Intravitreal Injection (Drug)
3
Experimental
700microgram dose of iCo-007 Intravitreal Injection
干预措施: iCo-007 Intravitreal Injection (Drug)
4
Experimental
1,000microgram dose of iCo-007 Intravitreal Injection
干预措施: iCo-007 Intravitreal Injection (Drug)
结局指标
主要结局
Safety and tolerability of 4 dose levels of intravitreal administration of iCo-007.
时间窗: At multiple points after injection up to and including 6 months
次要结局
- To assess the systemic pharmacokinetics of iCo-007 after intravitreal administration. To assess change in retinal thickness relative to baseline as determined by OCT. To assess change in best corrected visual acuity relative to baseline.(At multiple points after injection up to and including 6 months)
研究者
研究点 (4)
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