ACTRN12614001307695招募中4 期
A prospective, open-label clinical trial, to evaluate the efficacy of intravitreal Aflibercept for the treatment of treatment resistant diabetic macular oedema
Andrew Chang0 个研究点目标入组 50 人开始时间: 2014年12月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
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
- •*Ability to provide informed consent and complete study assessments
- •*Age 18 years or older
- •*Macular oedema involving in central macula secondary to type 1 or type 2 diabetic mellitus in study eye.
- •*Best corrected baseline visual acuity between 85-34 letters on early treatment in diabetic retinopathy study (ETDRS) chart (Snellen equivalent 6/6 to 6/60) on study eye
- •*Presence of central diabetic macular odema (DMO) >300 microns on spectral domain optical coherence tomography (SD-OCT) after at least 4 anti-VEGF (vascular endothelial growth factor) treatments within minimum of 6 months
- •*Documentation of the presence of macular oedema at least 30 days since last treatment.
排除标准
- •*Pregnancy or lactation
- •*Premenopausal women not using contraception
- •*Prior anti-VEGF injection in the study eye within 30 days of baseline
- •*Prior treatment with triamcinolone in the study eye within 3 months of baseline
- •*Intraocular surgery in the study eye within 2 months of baseline
- •*Macular laser within 2 months or previous laser scar would prevent the improvement of macular function
- •*Prior vitrectomy in the study eye within 3 months of baseline
- •*Current vitreous haemorrhage or inflammation in the study eye
- •*Uncontrolled glaucoma in the study eye. Intraocular pressure (IOP) greater than 30mmHg on maximal medical therapy.
- •*Active proliferative diabetic retinopathy (PDR) in the study eye.
- •*Ischemic maculopathy on fluorescein angiography defined as a total area of capillary loss greater than 2 disc areas (> 5mm2) within the ETDRS macular grid or a foveal avascular zone greatest linear diameter of > 1000 microns
- •*Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion)
- •*Macular oedema due to other causes including vitreous traction
- •*An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy)
- •*Uncontrolled diabetes mellitus, as defined by HbA1c > 12%
- •*Severe media opacity
- •*History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrollment
- •*Allergy to fluorescein dye.
- •*Uncontrolled high blood pressure (blood pressure > 180/110 mmHg)
研究者
相似试验
招募中
4 期
Intravitreal Aflibercept for the treatment of previously treated exudative age-related macular degeneratioACTRN12612000666820Andrew Chang70
已完成
不适用
A clinical trial to find the efficacy and safety of Tubby nutririch lotion for the treatment of dry skin in infants and children.CTRI/2012/08/002876Sante Mernaud Pharmaceuticals Pvt Ltd15
已完成
Unknown
Clinical trial on back pain patientsCTRI/2023/06/053694ITED MEDICARE15
招募中
不适用
Clinical trial of PROTECT-C hand sanitizer in SARS-CoV-2 infected subjects.CTRI/2021/07/034624MIYAKAWA KOGYO INDIA PVT LTD
暂停
不适用
A clinical trial of NanoAgCide hand sanitizer on Coronavirus patients.CTRI/2020/10/028688WeInnovate Biosolutions Pvt Ltd