Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With a Novel Treat and Extend Protocol - a Randomized Controlled Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Central Macular thickness
研究概览
简要总结
The investigator propose to conduct a randomized clinical trial, investigating the safety and efficacy of brolucizumab for treatment of nAMD patients with CNV, and plans to specifically target those who are not responding to standard Treat and Extend (T&E) treatment. A randomised omized study will be conducted with 2 arms, one with the new drug (brolocizumab) and novel treatment protocol versus a second arm using the current gold standard of aflibercept and the T&E protocol
详细描述
In addition, there will also be a rescue option for those in the aflibercept arm who are not responding well to also switch to brolucizumab. The primary outcome is the change in central macular thickness, since we expect the new treatment to be effective in reducing intraretinal and subretinal fluids, which in effect are indicators of disease activity. In addition, investigator will look at the improvement of visual acuity, the reduction of treatment intervals, total number of injections over 1 year, recurrence rate and safety profiles of both drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients are randomised and masked from the treatment
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
- •Age 50 and above
- •Diagnosis of exudative age-related macular degeneration (subfoveal CNV) as shown on optical coherence tomography (OCT) - presence of intraretinal fluid, subretinal fluid or subretinal hyperreflective material and/or FFA (leakage classified as subfoveal or as juxtafoveal or extrafoveal)
- •Actively treated with aflibercept and given 3 monthly loading doses followed by treat and extend
- •Maximal interval period is less than or equal to 8 weekly injections
- •Patients must understand and sign the ethics board approved consent form
排除标准
- •Ocular criteria:
- •Co-existing retinal and/or macular disease (DME, RVO, high myopia of 8 diopters or more, retinal detachment, macular hole stage 2 or above, significant vitreomacular traction or epiretinal membrane, etc.)
- •Co-existing ocular disease (glaucoma, uveitis etc.)
- •History of uveitis or intraocular inflammation, scleritis, or episcleritis
- •History of corneal transplant, pars planar vitrectomy or aphakia
- •History of therapeutic radiation to the region of the study eye
- •Media opacity obstructing investigation or assessment (cataract, corneal scar, vitreous hemorrhage)
- •Treat and extend period beyond 8 weeks
- •Any intravitreal injection of steroid within 3 months before randomization
- •Systemic criteria:
- •Poorly controlled systemic disease including hypertension and diabetes
- •Any acute coronary event or stroke within 6 months before randomization
- •Malignancy within 5 years
- •Systemic anti-VEGF treatment
- •Allergy or sensitivity to investigational product, including fluoresceine dye, anesthetics, aflibercept or brolucizumab
研究组 & 干预措施
Brolucizumab
new drug (brolocizumab) and novel treatment protocol
干预措施: Brolucizumab (Drug)
Aflibercept
aflibercept and continuing on the traditional T&E protocol. There will also be a rescue option for those in the aflibercept arm who are not responding well to also switch to brolocizumab
干预措施: Aflibercept (Drug)
结局指标
主要结局
Central Macular thickness
时间窗: 1 year
Measurement of the change in macular thickness (um)
次要结局
- Visual acuity(1 year)
- Treatment interval(1 year)
- Complications(1 year)
- Optical Coherence Tomography features(1 year)
研究者
Dr. Nicholas Fung
Clinical Assistant Professor
The University of Hong Kong