NCT04287348终止4 期
Intravitreal Brolucizumab in Neovascular Age-related Macular Degeneration With Limited Response to Aflibercept
Vista Klinik1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年7月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The primary outcome is the mean maximum treatment interval with intravitreal brolucizumab at month 6 and 12.
研究概览
简要总结
The purpose of this investigator initiated study is to identify the effects of intravitreal brolucizumab on recurrence-free treatment intervals and morphological features in choroidal neovascularizations (CNV) due to age-related macular degeneration (AMD) in which the Optical coherence tomography (OCT) guided treatment interval failed to be extended to 6, 8 or 10 weeks intervals in a treat and extend regimen using aflibercept.
详细描述
Outcome Measures:
The primary outcome is the mean maximum treatment interval with intravitreal brolucizumab at month 6 and 12.
The secondary outcomes are:
- Best corrected visual acuity (BCVA) in letters and BCVA change (letters) from baseline (=switch to brolucizumab) to month 6 and 12.
- Number of brolucizumab intravitreal treatments applied during the 12 months study period.
- Central retinal thickness (CRT, in µm) as measured in the central ETDRS subfield Spectral-Domain Optical coherence tomography (SD-OCT) at baseline, month 6 and 12.
- Presence of qualitative SD-OCT features like intraretinal fluid, subretinal fluid, pigment epithelial detachment and hyperreflective foci at baseline, month 6 and 12.
- Total CNV area and vessel density as measured by OCTangiography (OCTA) at baseline, month 6 and 12.
- Total area of leakage from CNV and the total lesion area as evaluated by Fluorescein angiography (FA) at baseline and month 12.
- VFQ-25 total and subscores as evaluated by quality of life questionnaire VFQ-25 at baseline and month 6 and 12.
- Rates of adverse events and serious adverse events at 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either ≥ 50% of the total lesion area or ≥ 1 disc area in size.
- •Presence of a retinal pigment epithelial tear involving the fovea in the study eye.
- •Patients with angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
- •Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12 months study period.
- •Vitreous hemorrhage or history of retinal detachment or macular hole (Stage 3 or 4) 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.
- •History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication).
- •Aphakia with absence of the posterior capsule in the study eye.
- •Any prior treatment in the study eye with radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, transpupillary thermotherapy.
- •History of submacular surgery or other surgical intervention for AMD in the study eye, glaucoma filtration surgery, corneal transplant surgery.
- •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.).
- •Use of other investigational drugs at the time of baseline, or within 30 days or 5 half- lives of baseline, whichever is longer (excluding vitamins and minerals).
- •Previous violation of the posterior capsule in the study eye unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/ml).
- •History of hypersensitivity or allergy to fluorescein.
- •Inability to obtain OCTs, OCTAs, fundus photographs or fluorescein angiograms of sufficient quality.
研究组 & 干预措施
Beovu (Brolucizumab)
Other
Prospective, one-treatment-arm, monocentre study
干预措施: Brolucizumab 6 mg solution for intravitreal injection (Drug)
结局指标
主要结局
The primary outcome is the mean maximum treatment interval with intravitreal brolucizumab at month 6 and 12.
时间窗: up to month 12
mean maximum treatment interval with intravitreal brolucizumab
次要结局
- VFQ-25 total evaluated by quality of life questionnaire VFQ-25 at baseline and month 6 and 12.(month 6 and 12)
- Total area of leakage from CNV(baseline and month 12)
- BCVA change (letters) from baseline (=switch to brolucizumab)(month 6 and 12)
- Number of brolucizumab intravitreal treatments applied during the 12 months study period.(12 months)
- the total lesion area as evaluated by Fluorescein angiography (FA) at baseline and month 12(baseline and month 12)
- VFQ-25 subscores(month 6 and 12)
- Best corrected visual acuity (BCVA) in letters(month 6 and 12)
- Central retinal thickness (CRT, in µm) as measured in the central ETDRS subfield Spectral-Domain Optical coherence tomography (SD-OCT) at baseline, month 6 and 12.(month 6 and 12)
- Presence of qualitative SD-OCT features like intraretinal fluid, subretinal fluid, pigment epithelial detachment and hyperreflective foci at baseline, month 6 and 12(month 6 and 12)
- Total CNV area and vessel density as measured by OCTangiography (OCTA) at baseline, month 6 and 12.(month 6 and 12)
- Rates of adverse events and serious adverse events at 6 and 12 months.(6 and 12 months.)
研究者
PD Dr. med. Katja Hatz
Head of Medical Retina and clinical Research department
Vista Klinik
研究点 (1)
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