ACTRN12611000302954招募中3 期
A 12 month, phase 3, single-centre, randomised trial to compare the the safety and efficacy of a 125mg/0.05ml Bevacizumab intravitreal injection to macular grid laser therapy in the treatment of macular edema following Branch Vein Retinal Occlusion (BRVO) .
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 22
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
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •> 18 years of age
- •Males and females
- •Duration of BRVO > 3 months
- •Best Correct Visual Acuity (BCVA) < 20/40
- •CRT > 250 micro m in the central subfield or >300microns in the inner subfield.
- •Adequate renal function (glomerular filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance > or = to 50 mL/minute)
排除标准
- •History of submacular surgery or other surgical intervention for Aged Macular Degeneration (AMD) in the study eye, glaucoma filtration surgery, corneal transplant surgery or diabetic maculopathy.
- •Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding baseline,
- •Extracapsular extraction of cataract with phacoemulsification within three months preceding Baseline, or a history of post-operative complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis, etc.),
- •History of uncontrolled glaucoma in the study eye (defined as intraocular pressure is greater than or equal to 25 mmHg despite treatment with anti-glaucoma medication),
- •Aphakia with absence of the posterior capsule in the study eye,
- •Active intraocular inflammation (grade trace or above) in the study eye,
- •Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated uveitis in either eye,
- •Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye,
- •Presence of a retinal pigment epithelial tear involving the macula in the study eye, Subfoveal fibrosis or significant atrophy in the study eye
- •Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
- •Known sensitivity to study drug(s) or class of study drug(s)
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
- •Use of any other investigational agent in the last 30 days
研究者
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