ACTRN12622001246774尚未招募4 期
Palmerston North Interventional Rapid Avastin Treat & Extend (PIRATE) study in low-risk age-related macular degeneration patients.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
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
- Open (masking not used)
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients greater than or equal to 50 years of age
- •Low-risk nvAMD characteristics (see risk-stratification outlined below) with likely subfoveal or juxtafoveal choroidal neovascular membrane (CNVM). These being diagnosed clinically, confirmed by investigator (ophthalmology registrar or ophthalmologist)
- •Deemed appropriate for Avastin therapy by investigator
- •Best corrected visual acuity (BCVA) between 6/12 - 6/180 at first visit in study eye
- •If both eyes affected then the eye with the worse BCVA will be included in the trial as the study eye
- •Participants must be willing and able to provide independent informed consent
- •Participants with be stratified based on their nAMD characteristics. High-risk participants will be deemed anyone who meets one or more of the following criteria:
- •1. Monocular patients (i.e. only have a single good-seeing eye)
- •2. Macular haemorrhage (greater or equal to 1 disc diameter) clinically or on fundus photo
- •3. History of previous of large macular haemorrhage
- •4. Subretinal fluids (SRF) less than 200 microns
- •5. Recent reduction of injection frequency for any reason (i.e. if shortened by 4 weeks, then further extensions will be at 2 week intervals or ‘usual treatment’ as in control group)
- •High-risk participants will NOT be included in the PIRATE study cohort. They will continue with the current standard anti-VEGF therapy. Low-risk participants will be deemed anyone who meets the inclusion criteria WITHOUT having any of the high-risk criteria outlined.
排除标准
- •Prior treatment of the study eye with intraocular anti-VEGF agents, verteporfin photodynamic therapy, other laser treatment, intraocular corticosteroids, surgical procedures (except cataract surgery greater than or equal to 30 days prior to screening)
- •Systemic use of anti-VEGF agents within 3 months prior to the study entry period
- •Active or suspected infection in or surrounding the study eye
- •Peripapillary CNVM
- •Active severe intraocular inflammation in the study eye
- •Intraocular pressure greater than 28mmHg in study eye
- •Ocular condition that might impact vision and confound study outcomes in the study eye (by the discretion of ophthalmology registrar or ophthalmologist)
- •History of Avastin allergy or related intravitreal administration agents (e.g. povidone iodine, lidocaine, gutt. Iopidine, gutt. Chloramphenicol)
- •Women who are pregnant, suspected to be pregnant or lactating
- •Previous or concomitant participation in another clinical study with investigational medicinal product(s) within last 3 months
- •Individuals who lack decision-making capacity who are not able to provide independent informed consent for the trial
- •Any other patient deemed ineligible by investigator (ophthalmology registrar or ophthalmologist)
研究者
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