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
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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