NCT02647515已完成4 期
Intravitreal Ranibizumab Injection as Adjuvant in the Treatment of Postvitrectomy Diabetic Vitreous Hemorrhage Accompanied by Neovascular Glaucoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- vitreous hemorrhage
研究概览
简要总结
To determine the efficacy of intravitreal ranibizumab injection as adjuvant therapy in the treatment of postvitrectomy diabetic vitreous hemorrhage (PDVH) accompanied by neovascular glaucoma (NVG) as a means of preventing recurrent vitreous hemorrhage （VH） and optimizing postoperative intraocular pressure（IOP）control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •age≥18 years
- •PDVH obscuring the disc and vessels for more than 14 days and no evidence of retinal detachment after primary vitrectomy for PDR-related complications such as nonclearing VH, macula-involving or macula-threatening tractional retinal detachment, or fibrovascular proliferation with vitreoretinal adhesions
- •NVG occurred following PDVH less than 4 weeks (NVG was diagnosed when an IOP elevation of 22mmHg or more was accompanied by neovascularization of the iris and/or the anterior chamber angle)
排除标准
- •intraoperative use of long-acting gas or silicone oil in primary vitrectomy, repeat vitrectomy after primary vitrectomy for retinal diseases other than VH, previous history of vitrectomy
- •previous intravitreal injection of ranibizumab or bevacizumab in either eye
- •previous intravitreal corticosteroids injection in either eye
- •pregnancy or current oral contraceptive intake
- •usage of clopidogrel bisulfate or coumadin
- •uncontrolled hypertension and cardiac disease
- •uncontrolled renal or liver disease
研究组 & 干预措施
ranibizumab
Experimental
干预措施: ranibizumab (Drug)
结局指标
主要结局
vitreous hemorrhage
时间窗: 12 months
intraocular pressure
时间窗: 12 months
次要结局
未报告次要终点
研究者
相似试验
已完成
3 期
Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal MelanomaChoroidal MelanomaNCT00680225New England Retina Associates10
已完成
2 期
Intravitreal Ranibizumab (Lucentis®) in the Treatment of Non-leaking Macular Cysts in Retinal DystrophyRetinal DystrophiesNCT03763227Sultan Qaboos University13
已完成
不适用
Intravitreal Ranibizumab in Exudative Age-related Macular Degeneration With Posterior Vitreomacular AdhesionNeovascular Age-related Macular DegenerationNCT01291121Yonsei University30
已完成
4 期
Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular GlaucomaGlaucoma, NeovascularNCT01922154Siriraj Hospital15
已完成
2 期
Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)Proliferative Diabetic RetinopathyVitreous HemorrhageNCT00996437Jaeb Center for Health Research261