Zoledronic acid as adjuvant therapy in neovascular Age-related Macular Degeneration (The Z-AMD study): a randomized controlled pilot study

Oslo University Hospital0 个研究点目标入组 40 人开始时间: 2019年5月15日最近更新: 2024年2月19日

适应症

试验速览

暂无简介。

•1. 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).
•2. Age =50 years
•3. Best-corrected visual acuity (BCVA) between 0.1 and 1.0 logMAR
•4. Menopausal for at least one year
•5. Only one eye per patient will be recruited for the study. If both eyes are eligible for the study, the eye with the worse best-corrected visual acuity (BCVA) will be selected as the study eye.
•6. Subjects must give written informed consent before any study related procedures are performed
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 36

•1. Lesions comprising more than 50% blood or fibrosis involving the fovea centre
•2. Polypoidal choroidal vasculopathy (PCV) - indocyanine green is performed at the discretion of the investigator on clinical suspicion of PCV
•3. Presence of other ocular disease causing concurrent vision loss
•4.Presence of ocular disease making intravitreal treatment contraindicated (e.g. current ocular or periocular infection, active uveitis or uncontrolled glaucoma/intraocular pressure = 25 mmHg)
•5.Systemic anti-vascular endothelial growth factor (anti-VEGF) within one year preceding the initial study treatment
•6. Bisphosphonate treatment for osteoporosis within ten years preceding the initial study treatment , or any prior bisphosphonate treatment as an adjuvant to cancer therapy
•7.Confirmed or suspected active malignancy.
•8.Other factors (i.e. lack of cooperation) that, in the opinion of the investigator, can interfere with the study protocol
•9.Known or suspected hypersensitivity to any of the trial products
•10.Hypocalcemia (total Ca < 2.15 mmol/L)
•11. Renal impairment (estimated ClCR < 35 ml/min)

发起方

Oslo University Hospital