NCT00692614终止2 期
A Phase IIb, Randomized, Masked, Sham-Controlled, Clinical Trial to Study the Efficacy and Safety of the Helical Triamcinolone Acetonide Implant (MK0140) in Diabetic Patients With Clinically Significant Macular Edema
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
- 2
- 主要终点
- Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses.
研究概览
简要总结
This study will evaluate the treatment effect of three doses of the I-vation TA implant (MK0140) in diabetic patients with clinically significant macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patient has clinically significant macular edema as a result of their diabetes (Type I or Type 2)
- •Patient has in the study eye, 20/40 - 20/160 vision
- •Patient has Type 1 or Type 2 diabetes
- •Patient agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control
排除标准
- •Patient has had any active ocular infection in either eye
- •Patient has intraocular pressure > 22 mmHg or a diagnosis of glaucoma
- •Patient has cystoid macular edema in the study eye
- •Patient has a history of elevated IOP in response to ocular steroid therapy in either eye
- •Patient has had intraocular surgery in the study eye within 6 months prior to Visit 1
- •Patient has an HbAIc value > 10% at Visit 1
- •Patient has within the last 4 months initiated intensive insulin treatment or plan to do so in the next 4 months
- •Patient has a history of cancer within 5 years prior to signing informed consent
- •Patient has clinically-relevant chronic renal failure
- •Patient has high blood pressure
- •Patient has coronary heart disease
- •Patient has known allergies to steroids
研究组 & 干预措施
1
Experimental
100 mcg triamcinolone acetonide
干预措施: triamcinolone acetonide (Drug)
2
Experimental
500 mcg triamcinolone acetonide
干预措施: triamcinolone acetonide (Drug)
3
Experimental
925 mcg triamcinolone acetonide
干预措施: triamcinolone acetonide (Drug)
结局指标
主要结局
Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses.
时间窗: After 12 months of therapy.
次要结局
- Evaluation of visual acuity; change from baseline in OCT center-point retinal thickness; the need for focal/grid laser photocoagulation during the study; the progression of diabetic retinopathy(After 12 months of therapy.)
研究者
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Unknown
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