Zoledronic Acid as Adjuvant Therapy in Neovascular Age-related Macular Degeneration (The Z-AMD Study): A Randomized Controlled Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean change from baseline in best-corrected visual acuity (BCVA) after 52 weeks.
研究概览
简要总结
A pilot study of zoledronic acid as adjuvant therapy to standard anti-vascular endothelial growth factor (anti-VEGF) treatment for neovascular age-related macular degeneration (AMD).
详细描述
This is a one-year, randomized, controlled pilot study. A total of 40 treatment-naïve nAMD patients will be allocated 1:1 to receive an intravenous infusion of either zoledronic acid (ZA) 5 mg or placebo at baseline and after 26 weeks as adjuvant therapy to intravitreal anti-VEGF injections in accordance with a treat and extend algorithm; bevacizumab is the first-line treatment, and refractory eyes are converted to aflibercept.
The participants will be recruited among patients admitted to the Department of Ophthalmology at Oslo University Hospital (OUH). The department is the largest provider of retinal care in Norway and serves a local community of almost one million people, which makes it well-suited for recruitment. Administration of ZA or placebo will take place at Pilestredet Park Specialist Centre, an endocrinology clinic in Oslo with particular interest in treatment of osteoporosis. The Clinical Trial Unit at OUH will monitor the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Active, treatment-naïve neovascular AMD in the study eye, intraretinal or subretinal fluid involving the fovea centre on optical coherence tomography (OCT), and evidence of choroidal neovascularization on fluorescein angiography (FA) and/or OCT angiography (OCT-A).
- •Age ≥50 years
- •Best-corrected visual acuity (BCVA) between 0.1 and 1.0 logMAR
- •Menopausal for at least one year
- •Only one eye per patient will be recruited for the study. If both eyes are eligible for the study, the eye with the wors best-corrected Visual acuity (BCVA) will be selected as the study eye.
- •Subjects must give written informed consent before any study related procedures are performed
排除标准
- •Lesions comprising more than 50% blood or fibrosis involving the fovea centre
- •Polypoidal choroidal vasculopathy (PCV) - indocyanine green (ICG) angiography is performed at the discretion of the investigator on clinical suspicion of PCV
- •Presence of other ocular disease causing concurrent vision loss
- •Presence of ocular disease making intravitreal treatment contraindicated (e.g. current ocular or periocular infection, active uveitis or uncontrolled glaucoma/intraocular pressure ≥ 25 mmHg)
- •Systemic anti-vascular endothelial growth factor (anti-VEGF) or bisphosphonate treatment within one year preceding the initial study treatment
- •Confirmed or suspected active malignancy
- •Other factors (i.e. lack of cooperation) that, in the opinion of the investigator, can interfere with the study protocol
- •Known or suspected hypersensitivity to any of the trial products
- •Hypocalcemia (total Ca < 2.15 mmol/L)
- •Renal impairment (estimated ClCR < 35 ml/min).
研究组 & 干预措施
Investigational Medical Product : Zoledronic acid
Zoledronic acid 5 mg IV at baseline and after 26 weeks.
干预措施: Zoledronic Acid 5 MG in 5 ML Injection (Drug)
Placebo: NaCl 0,9%
100 ml 0.9% NaCl IV at baseline and after 26 weeks.
干预措施: Placebos (Drug)
结局指标
主要结局
Mean change from baseline in best-corrected visual acuity (BCVA) after 52 weeks.
时间窗: 52 weeks
To assess the change in best-corrected visual acuity measured by logMAR.
次要结局
- The number of anti-VEGF intravitreal injections given after 52 weeks(52 weeks)
- Number of patients with a change in BCVA of 0.3 logMAR or more after 52 weeks.(52 weeks)
- Proportion of patients experiencing adverse events of special interest (ESI): osteonecrosis of the jaw or atypical femoral fracture, endophthalmitis or orbital, scleral, or serious intraocular inflammation (grade 4 aqueous cells/FLARE).(52 weeks)
- Proportion of patients with refractory nAMD after 52 weeks.(52 weeks)
- EQ 5D score (ranging from 0-1; 0 designates "perfect health" and NEI-VFQ-25 score (ranging from 0 to 100 where 100 reflects best vision-specific health).(52 weeks)
- Mean change from baseline in Central retinal thickness (CRT) after 52 weeks.(52 weeks)
研究者
Morten Carstens Moe
MD, Professor in Ophthalmology
Oslo University Hospital