ACTRN12621000305820终止4 期
Brolucizumab Treatment For Pigment Epithelial Detachment In Treatment-Resistant Neovascular Age Related Macular Degeneration
Sydney Retina Clinic & Day Surgery0 个研究点目标入组 10 人开始时间: 2021年3月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
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
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •Subjects must give written informed consent before any study related procedures are performed
- •Subjects must be 50 years of age or older at baseline
- •Pigment epithelial detachment (PED) secondary to neovascular macular degeneration (AMD). PED is defined as a discrete or localised dome-shaped or irregular elevation of the retinal pigment epithelium (RPE) on SD-OCT that was optically empty (i.e. serous) with a focus of neovascularisation at the edge or that was comprised of heterogeneous tissue of mixed reflectivity or layering within the sub-PED compartment.
- •Previously treated neovascular age-related macular degeneration, treatment resistance” is defined as eyes with persistent active/exudation despite at least 4 previous ranibizumab and/or aflibercept treatments in the 6 months prior to baseline, not including loading dose, with a minimal interval of 8 weeks between the last anti-vascular endothelial growth factor (anti-VEGF) injection and the baseline injection
- •Best corrected baseline visual acuity between 20-78 letters on ETDRS chart (Snellen equivalent 6/12 to 6/120) in the study eye.
- •Active choroidal neovascularisation (CNV) lesions secondary to AMD that affect the central subfield (excluding retinal angiomatous proliferation [RAP] and polypoidal vasculopathy [PCV]) in the study eye, confirmed by the angiography and Principal Investigator.
- •Total area of CNV must comprise >50% of the total lesion area in the study eye.
- •Intra and or subretinal fluid affecting the central subfield of the study eye.
排除标准
- •Any active intraocular or periocular infection or active intraocular inflammation (eg, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Baseline
- •Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by colour fundus photography autofluorescence.
- •Total area of fibrosis greater than or equal to 50% of the total lesion in the study eye
- •Subretinal blood affecting the central subfield and/or greater than or equal to 50% of the lesion of the study eye
- •Subject has received any investigational treatment for neovascular AMD (other than vitamin supplements) in the study eye at any time
- •Eyes diagnosed with Retinal Angiomatous Proliferation or Polypoidal Choroidal Vasculopathy lesion
- •Any history or evidence of a concurrent intraocular condition in the study eye, including retinal diseases other than neovascular AMD, that, in the judgment of the Investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition or that limits the potential to gain visual acuity upon treatment with the investigational product
- •Retinal pigment epithelium (RPE) rip/tear in the study eye at Baseline
- •Current vitreous haemorrhage or history of vitreous haemorrhage in the study eye within 4 weeks prior to Baseline
- •History or evidence of the following in the study eye:
- •Previous photodynamic therapy (PDT)
- •Intraocular or refractive surgery within the 90-day period prior to Baseline
- •Previous penetrating keratoplasty or vitrectomy
- •Previous panretinal photocoagulation
- •Previous submacular surgery, other surgical intervention or laser treatment for AMD
- •Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to Investigator’s judgment at Baseline
- •Aphakia and/or absence of the posterior capsule in the study eye at Screening or Baseline
- •Intra- or periocular use of corticosteroids in the study eye during the 6-month period prior to Baseline
- •Use of topical ocular corticosteroids in the study eye for 60 or more consecutive days within the 90-day period prior to Baseline
- •Use of systemic corticosteroids for 30 or more consecutive days within the 90 days prior to Baseline, with the exception of low stable doses of corticosteroids (defined as less than or equal to 10 mg prednisolone or equivalent dose used for 90 days or more). Inhaled, nasal or dermal steroids are also permitted
- •Previous therapeutic radiation near the region of the study eye
- •History of a medical condition (disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product
- •History of hypersensitivity to any component of the test article, control article, or clinically relevant sensitivity to fluorescein dye (or indocyanine green), as assessed by the Investigator
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG pregnancy test and women of child-bearing potential, defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization at Baseline, unless they are using effective methods of contraception during dosing of
研究者
相似试验
进行中（未招募）
不适用
Photodynamic Therapy for Basal Cell Carcinoma of the Eyelid and Periocular Skin with methyl aminolevulinate - PDT for periocular BCCPeriocular basal cell carcinomaMedDRA version: 9.1Level: LLTClassification code 10004146Term: Basal cell carcinomaMedDRA version: 9.1Level: LLTClassification code 10004148Term: Basal cell carcinoma excisionEUCTR2007-004085-41-GBThe Royal Wolverhampton Hospitals NHS Trust15
招募中
2 期
Mizollibin Therapy for Pigmented Villonodular Synovitis or Giant cell tumor of tendon sheathPatients with pigmented villonodular synovitis or giant cell tumor of tendon sheathJPRN-UMIN000004056Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University15
进行中（未招募）
不适用
Botulinumtoxin A Treatment in Epidermolysis Bullosa Simplex and Pachyonychia congenita-a double-blind placebo-controlled phase II proof of concept studyEpidermolysis Bullosa Simplex and Pachyonychia CongenitaEUCTR2009-010763-17-SESophiahemmet
招募中
2 期
Pembrolizumab for locally advanced, irresectable, non-metastatic dMMR colorectal cancers. The PUMA study.10017991colorectal cancerNL-OMON51364Antoni van Leeuwenhoek Ziekenhuis25
进行中（未招募）
1 期
Pembrolizumab for locally advanced, irresectable, non-metastatic dMMR colorectal cancers. The PUMA study.ocally advanced, irresectable dMMR colorectal cancersCTIS2023-509707-32-00Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting25