Status:
COMPLETED
Zoledronic Acid as Adjuvant Therapy in Neovascular Age-related Macular Degeneration (Z-AMD)
Lead Sponsor:
Oslo University Hospital
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
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).
Detailed Description
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 plac...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
October 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04304755
Start Date
October 25 2021
End Date
January 24 2024
Last Update
April 5 2024
Active Locations (2)
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1
Spesialistsenteret Pilestredet Park
Oslo, Norway, 0176
2
Oslo university hospital, Department of Ophthamology
Oslo, Norway, 0407