ACTRN12615000185561终止2 期
The effect of Tenecteplase on intravenous thrombus and retinal blood flow in patients with branch retinal vein occlusion (BRVO).
ions Eye Institute0 个研究点目标入组 10 人开始时间: 2015年2月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Foveal centre involved macular oedema secondary to BRVO less than 3 weeks in duration.
- •2. Major supero-temperal or infero-temperal BRVO.
- •3. Mean central foveal thickness greater or equal to 250 microns on spectral domain OCT.
- •4. Adults greater or equal to 18 years.
- •5. Best corrected visual acuity 20/40 to 20/320 (73-24 letters on ETDRS chart).
- •6. Clear ocular media and adequate pupillary dilation.
- •7. Intraocular pressure equal or less than 25mmHg.
- •8. Written informed consent.
- •9. No other significant ocular pathology.
- •10. Willing, committed and able to return for all clinic visits and complete all study related procedures.
排除标准
- •1.Any previous treatment for BRVO.
- •2. Brisk afferent pupillary defect.
- •3. Evidence on examination of any diabetic retinopathy.
- •4. Women of child bearing potential not using contraception, as well as women who are breastfeeding.
- •5. Known sensitivity to study drug or class of study drug.
- •6. Use of any other investigational agent in the last 30 days.
- •7. Any other ocular condition in the study eye that would prevent improvement in visual acuity, e.g.macular ischaemia, underlying macular degeneration, epi-retinal membrane.
- •8. Neovascularisation of the iris, dics or retina.
- •9. Previous treatment with intravitreal corticosteroids, intravitreal anti-VEGF agents or macular grid laser in the previous 3 months.
- •10. Aphakia or presence of anterior chamber lens in the study eye.
- •11. Significant media opacities such as cataract.
- •12. Previous pars plana vitrectomy.
- •13. History of retinal detachment or surgery for retinal detachment.
- •14. Any condition which would preclude a patient's ability to comply with the study requirements or to be available for the duration of the study.
- •15. Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, sclertitis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye.
- •16. Extra capsular extraction of cataract with phacoemulsification within 3 months preceding baseline, or a history of post-operative complications within 12 months preceding baseline in the study eye (uveitis, cyclitis etc.).
- •17. Contra indication to pupil dilation in either eye.
- •18. Allergy to fluorescein.
研究者
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