Zoledronic Acid as Adjuvant Therapy in Neovascular Age-related Macular Degeneration (Z-AMD)

Korábbi kezelés

• Presence of other ocular disease causing concurrent vision loss

Más betegség

• Presence of ocular disease making intravitreal treatment contraindicated (e.g. current ocular or periocular infection, active uveitis or uncontrolled glaucoma/intraocular pressure ≥ 25 mmHg)
• Confirmed or suspected active malignancy
• Known or suspected hypersensitivity to any of the trial products
• Renal impairment (estimated ClCR < 35 ml/min).

Laborértékek

• Hypocalcemia (total Ca < 2.15 mmol/L)

Egyéb

• 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
• Systemic anti-vascular endothelial growth factor (anti-VEGF) or bisphosphonate treatment within one year preceding the initial study treatment
• Other factors (i.e. lack of cooperation) that, in the opinion of the investigator, can interfere with the study protocol

• 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