NCT00695318终止2 期
A Randomized, Double-Masked, Fellow-Eye Comparison Of The Safety And Efficacy Of 0.2 And 0.5 µg/Day Fluocinolone Acetonide Intravitreal Insert To Sham Injection In Subjects With Bilateral Geographic Atrophy Due To AMD
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
- 17
- 试验地点
- 1
- 主要终点
- Change From Baseline in Size of Geographic Atrophy
研究概览
简要总结
This study will compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.
详细描述
Each patient received a sham injection in one eye and active treatment in the other eye. The eye receiving active treatment was selected based on a randomization schedule.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis bilateral GA secondary to AMD of ≥ 0.5 and ≤ 7 MPS disc areas
- •Males and non-pregnant females 55 years old or older
排除标准
- •GA secondary to any condition other than AMD in either eye
- •History of or current CNV in either eye or the need for anti-angiogenic therapy
- •Glaucoma or ocular hypertension (IOP > 21 mmHg OR concurrent therapy at screening with IOP-lowering agents) in either eye
- •Treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to enrollment in either eye
- •Any change in systemic steroid therapy within 3 months of screening
- •History of vitrectomy in either eye
- •Any ocular surgery within 12 weeks of screening in either eye
研究组 & 干预措施
A, 2, I 0.2 µg/Day + Sham
Experimental
0.2 µg/Day
干预措施: Fluocinolone Acetonide (Drug)
A, 2, II 0.5 µg/Day + Sham
Experimental
0.5 µg/Day
干预措施: Fluocinolone Acetonide (Drug)
结局指标
主要结局
Change From Baseline in Size of Geographic Atrophy
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery SubjectsOcular InflammationNCT01808547Sun Pharmaceutical Industries Limited268
已完成
3 期
Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery SubjectsOcular InflammationNCT01576952Sun Pharmaceutical Industries Limited268
已完成
2 期
A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)Wet Macular DegenerationNeovascular Age-related Macular DegenerationMacular DegenerationNCT05637255Sylentis, S.A.99
已完成
1 期
Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery VolunteersOcular InflammationNCT01190878Sun Pharmaceutical Industries Limited169
已完成
4 期
Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.CataractNCT04631315Laboratorios Poen255