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临床试验/ACTRN12612000666820
ACTRN12612000666820招募中4 期

A prospective, open-label clinical trial, to evaluate the efficacy of intravitreal Aflibercept for the treatment of previously treated exudative age-related macular degeneration

Andrew Chang0 个研究点目标入组 70 人开始时间: 2012年6月21日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
70

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
50 Years 至 o limit(—)
性别
All

入选标准

  • 1. Ability to provide informed consent and complying with the study assessments who are the
  • 2. Age 50 years or older
  • 3. Choroidal neovascularization secondary to age-realted macular degeneration
  • 4. Best corrected vision between 6/6 to 6/60 on EDTRS chart
  • 5. Presence of subretinal fluid or cystic intraretinal oedema on optical coherence tomography after at least 4 anti-VEGF treatments within minimum of 6 months and maximum of 3 years before enrollment of the study
  • 6. Documentation of the presence of subretinal fluid or cystoid oedema less than 30 days since last treatment.

排除标准

  • 1. Pregnancy or lactation
  • 2. Premenopausal women not using contraception
  • 3. Prior anti-VEGF injection in the study eye within 30 days of baseline
  • 4. Prior treatment with PDT (Visudyne) within 90 days of baseline and more than 6 prior PDT treatments
  • 5. Significant subretinal fibrosis or atrophy
  • 6. Prior treatment with triamcinolone in the study eye within 6 months of baseline
  • 7. Intraocular surgery in the study eye within 2 months of baseline
  • 8. Prior vitrectomy or other surgical intervention for age-realted macular degeneration in the study eye
  • 9. Current vitreous haemorrhage or inflammation in the study eye
  • 10. Uncontrolled glaucoma I the study eye. Intraocular pressure greater than 30mmHg on maximal medical therapy
  • 11. History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrollment
  • 12. Allergy to fluorescein and indocyanine green dye.

研究者

发起方
Andrew Chang

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