NCT00114062终止2 期
A Randomized, Double-Masked, Parallel Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Uveitis Associated Macular Edema
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 主要终点
- Assess the utility of denufosol in treating uveitis associated macular edema.
研究概览
简要总结
The purpose of this study is to determine whether denufosol tetrasodium (INS37217) Intravitreal Injection is well tolerated and has the potential to treat uveitis associated macular edema.
详细描述
Denufosol tetrasodium (INS37217) Intravitreal Injection may provide clinical benefit in treatment of uveitis associated macular edema (UME) by reducing retinal thickness as measured by OCT and possibly enabling recovery of vision loss associated with UME. Denufosol tetrasodium may also reverse the fluid accumulation of UME.
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
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
- •Have anterior uveitis, intermediate uveitis, posterior uveitis or panuveitis in at least one eye
- •Have persistent macular edema and uveitis whose conditions are stable
- •Have no change in medication regimen for at least 3 months prior to randomization if currently taking medications such as immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents (drops, oral or injected)
- •Have an OCT scan with a qualifying retinal thickness in the study eye
- •Have evidence of macular edema on OCT scan
- •Have at lease one eligible eye to be treated in the study based on visual acuity.
排除标准
- •Have proliferative vitreoretinopathy greater than grade B
- •Have subretinal or vitreous hemorrhage, corneal opacity, or other conditions, which limit the view of the retina or obscure FA
- •Have uncontrollable elevated IOP, advanced, previous filtration surgery, or any current evidence of endophthalmitis in the study eye
- •Have ocular disorders in the study eye that may confound interpretation of study results
- •Have had cataract surgery in the study eye within 3 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
- •Have pre-operative spherical equivalent refractive error of more than -10 diopters of myopia in the study eye
- •Have had any intravitreal or periocular injection or corticosteroids in the study eye during the 3 months prior to screening
- •Have any ocular implant device for the delivery of therapeutic agents to the eye
- •Be taking any excluded medications that could obscure or confound study results
结局指标
主要结局
Assess the utility of denufosol in treating uveitis associated macular edema.
Evaluate the safety and tolerability of denufosol in subjects presenting with uveitis associated macular edema.
次要结局
- Pilot study - not specified
研究者
相似试验
已完成
3 期
Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)Dry Eye DiseaseNCT00600288Merck Sharp & Dohme LLC261
已完成
1 期
A Study in Subjects With Retinal DetachmentRetinal DetachmentNCT00210067Merck Sharp & Dohme LLC14
招募中
2 期
Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMDGeographic Atrophy (GA)Age - Related Macular Degeneration (AMD)NCT06659445ONL Therapeutics324
终止
3 期
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® MonotherapyAge-Related Macular DegenerationNCT01940900Ophthotech Corporation627
终止
3 期
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® MonotherapyAge-Related Macular DegenerationNCT01944839Ophthotech Corporation619