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临床试验/ACTRN12615000417583
ACTRN12615000417583已完成3 期

The efficacy of intravitreal aflibercept given in a ‘treat and extend’ regime in the treatment of cystoid macular oedema secondary to central retinal vein occlusion

Centre for Eye Research Australia0 个研究点目标入组 20 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
20

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. Age greater than or equal to18 years
  • 2. CRVO with cystoid macular as determined by fluorescein angiography and duration of onset less than 12 months
  • 3. Best-corrected visual acuity (BCVA) of 17-70 letters (6/12 –6/120)
  • 4. Central macular thickness of greater than or equal to 300 microns as measured by Heidelberg Optical coherence tomography.
  • 5. Absent relative afferent pupillary defect

排除标准

  • 1. Uncontrolled blood pressure (greater than or equal to180 mmHg, systolic and 110 mmHg, diastolic)
  • 2. Chronic renal failure
  • 3. Major surgery within one month of study
  • 4. Previous systemic anti-VEGF treatment
  • 5. Women of childbearing potential not using adequate contraception and women who are breast feeding
  • 6. Intercurrent severe disease such as septicaemia
  • 1. Glaucoma which is uncontrolled with intraocular pressure-lowering medications
  • 2. Past history of severe steroid response with IOP greater than or equal to 35 mmHg following steroid treatment
  • 3. Loss of vision due to other causes (e.g. age-related macular degeneration, myopic macular degeneration)
  • 4. VA of <6/60 in the fellow eye
  • 5. Argon laser photocoagulation within 3 months of study entry
  • 6. Previous intraocular surgery (within 6 months)
  • 7. Stroke or myocardial infarction less than 3 months prior to screening.
  • 8. Any active periocular or ocular infection or inflammation at screening or baseline.
  • 9. Subjects, who in the opinion of the Investigator, may not benefit from the Investigational Product due to pre-existing or current macular condition (eg, vitreomacular traction, epiretinal membrane, scar, foveal atrophy)

研究者

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