NCT00770770终止2 期
A Randomized, Double-masked, Pilot Study of the Safety and Efficacy of 0.5 µg/Day and 0.2 µg/Day Iluvien™ (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg in Subjects With Macular Edema Secondary to Retinal Vein Occlusion
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
- 20
- 试验地点
- 3
- 主要终点
- Visual Acuity
研究概览
简要总结
This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.
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
- Double (Participant, Investigator)
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
- •Diagnosis of macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
- •Central subfield thickness > 300 μm
- •BCVA of ≥ 24 and ≤ 68 letters
- •Males and non-pregnant females 18 years and over
排除标准
- •Macular edema secondary to any condition other than RVO
- •Presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in the study eye
- •Cystic intraretinal hemorrhage involving the fovea in the study eye that is responsible for vision loss
- •Glaucoma or ocular hypertension (IOP > 21 mmHg or concurrent therapy at screening with IOP-lowering agents)
- •Any prior treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy since the diagnosis of RVO in the study eye
- •Any change in systemic steroid therapy within 3 months of screening
- •History of vitrectomy in the study eye
研究组 & 干预措施
Fluocinolone Acetonide 0.2 µg/day
Experimental
0.2 µg/day
干预措施: Fluocinolone Acetonide (Drug)
Fluocinolone Acetonide 0.5 µg/day
Experimental
0.5 µg/day
干预措施: Fluocinolone Acetonide (Drug)
结局指标
主要结局
Visual Acuity
时间窗: 3 months
To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.
次要结局
未报告次要终点
研究者
研究点 (3)
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