Overview

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

Status:
Not yet recruiting
Trial end date:
2023-09-13
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Oslo University Hospital
Treatments:
Zoledronic Acid
Criteria
Inclusion Criteria:

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 wors 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

Exclusion Criteria:

1. Lesions comprising more than 50% blood or fibrosis involving the fovea centre

2. Polypoidal choroidal vasculopathy (PCV) - indocyanine green (ICG) angiography 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) or bisphosphonate
treatment within one year preceding the initial study treatment

6. Confirmed or suspected active malignancy

7. Other factors (i.e. lack of cooperation) that, in the opinion of the investigator, can
interfere with the study protocol

8. Known or suspected hypersensitivity to any of the trial products

9. Hypocalcemia (total Ca < 2.15 mmol/L)

10. Renal impairment (estimated ClCR < 35 ml/min).