NCT04304755CompletedPhase 2
Zoledronic Acid as Adjuvant Therapy in Neovascular Age-related Macular Degeneration (Z-AMD)
Zoledronic Acid as Adjuvant Therapy in Neovascular Age-related Macular Degeneration (The Z-AMD Study): A Randomized Controlled Pilot Study
Source: ClinicalTrials.gov · Last updated 5 Apr 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 23 Feb 2020
- Start date
- 25 Oct 2021
- Primary completion date
- 24 Jan 2024
- Lead sponsor
- Oslo University Hospital
- Diseases
- Macular degeneration
- NCT number
- NCT04304755
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 25 Oct 2021 to the primary completion date, 24 Jan 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of other ocular disease causing concurrent vision loss
Other illness
- 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).
Lab values
- Hypocalcemia (total Ca \< 2.15 mmol/L)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Spesialistsenteret Pilestredet Park Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Oslo university hospital, Department of Ophthamology Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.