ACTRN12615001094561进行中(未招募)4 期
The combination treatment of laser induced chorioretinal venous anastomosis and Lucentis for macula oedema that is secondary to central retinal vein occlusion, compared to the published results of Lucentis treatment only, a phase IV study.
ions Eye Institute0 个研究点目标入组 90 人开始时间: 2015年10月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 90
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not 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 perfused macular oedema secondary to CRVO.
- •2. Mean central foveal thickness greater or equal to 250 microns on spectral domain OCT.
- •3. Adults greater or equal to 18 years.
- •4. Clear ocular media and adequate pupillary dilation.
- •5. IOP less or equal to 25mmHg.
- •6. Written informed consent.
- •7. No other significant pathology.
- •8. Willing, committed and able to return for all clinic visits and complete all study related procedures.
- •9. Patients who have had a previous CRVO that has spontaneously resolved will be enrolled provided there is no evidence of macular damage that would confuse visual acuity improvements.
排除标准
- •1. Brisk afferent pupillary defect.
- •2. Evidence on examination of any diabetic retinopathy.
- •3. CVA or MI within 3 months prior to Baseline.
- •4. Women of childbearing potential not using the contraception method(s) specified in this study, as well as women who are breastfeeding.
- •5. Known sensitivity to study drug(s) or class of study drug(s).
- •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, disc or retina.
- •9. Aphakia or presence of anterior chamber lens in the study eye.
- •10. Significant media opacities such as cataract.
- •11. Previous pars plana vitrectomy.
- •12. History of retinal detachment or surgery for retinal detachment.
- •13. 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.
- •14. Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, sclertitis, endophthalmitis as well as idiopathic or autoimmune associated uveitis in either eye.
- •15. Extra capsular extraction of cataract with phacoemulsification within three months preceding baseline, or a history of post-operative complications within the last 12 months preceding baseline in the study eye (uveitis, cyclitis etc.).
- •16. Contra indication to pupil dilation in either eye.
- •17. Anticoagulation with warfarin or other significant anticoagulation drugs.
研究者
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