Phase I/II Study of Intravitreal Triamcinolone Acetonide Microspheres for Treatment of Diffuse Diabetic Macular Edema Unresponsive to Conventional Laser Photocoagulation Treatment.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide.
研究概览
简要总结
Phase I/II study with intravitreal triamcinolone acetonide microspheres(RETAAC)for treatment of diffuse diabetic macular edema unresponsive to laser photocoagulation. Study hypothesis is that single intravitreal injection of RETAAC is safe and efficient compared to conventional treatment. Fifty patients will participate in this study and will be randomized into treatment and observation groups. Efficacy will be evaluated by best corrected visual acuity and macular thickness measured by optic coherence tomography (OCT) after 12 months of treatment.
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
- •Diabetes mellitus (type 1 or 2)
- •Diabetic macular edema in study eye associated to diabetic retinopathy
- •Diffuse macular edema defined as macular thickening determined by biomicroscopy and fluorescein angiography.
- •Best corrected visual acuity between 34 (20/200) and 68 letters (20/50).
- •Macular thickness greater than 300 mcm on OCT.
排除标准
- •Uncontrolled systemic disease
- •Start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit.
- •HbA1c levels greater than 10%
- •Presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema.
- •Presence of epiretinal membrane
- •Presence of vitreomacular traction in the study eye.
- •Aphakic or anterior chamber intraocular lens in the study eye.
- •Neovascularization of disc or elsewhere in the study eye.
- •History or presence of choroidal neovascularization in the study eye.
- •Presence of rubeosis irides in the study eye.
- •Eye opacity that interfere with clinical documentation and photography.
- •Intra-ocular surgery 90 days before initial visit.
- •Previous vitrectomy in study eye.
- •Previous history of intravitreal or periocular corticoid or any other intravitreal drug in study eye.
- •Scheduled surgery for study eye.
- •Patients with known allergies to fluorescein, iodo-povidone or any component of study drug.
结局指标
主要结局
Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide.
时间窗: 12 months
Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment.
时间窗: 12 months
Safety of intravitreal triamcinolone acetonide after 12 months of treatment.
时间窗: 12 months
次要结局
未报告次要终点