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

NCT ID: NCT04304755

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2024-01-24

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 placebo at baseline and after 26 weeks as adjuvant therapy to intravitreal anti-VEGF injections in accordance with a treat and extend algorithm; bevacizumab is the first-line treatment, and refractory eyes are converted to aflibercept.

The participants will be recruited among patients admitted to the Department of Ophthalmology at Oslo University Hospital (OUH). The department is the largest provider of retinal care in Norway and serves a local community of almost one million people, which makes it well-suited for recruitment. Administration of ZA or placebo will take place at Pilestredet Park Specialist Centre, an endocrinology clinic in Oslo with particular interest in treatment of osteoporosis. The Clinical Trial Unit at OUH will monitor the study.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Investigational Medical Product : Zoledronic acid

Zoledronic acid 5 mg IV at baseline and after 26 weeks.

Group Type: EXPERIMENTAL

Zoledronic Acid 5 MG in 5 ML Injection

Intervention Type: DRUG

Zoledronic acid

Placebo: NaCl 0,9%

100 ml 0.9% NaCl IV at baseline and after 26 weeks.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

NaCl 0.9%

Interventions

Zoledronic Acid 5 MG in 5 ML Injection

Zoledronic acid

Intervention Type: DRUG

Placebos

NaCl 0.9%

Intervention Type: DRUG

Other Intervention Names

ZA; NaCl

Eligibility 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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Morten Carstens Moe

MD, Professor in Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Morten C Moe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Spesialistsenteret Pilestredet Park

Oslo, , Norway

Oslo university hospital, Department of Ophthamology

Oslo, , Norway

Countries

Norway

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019/583

Identifier Type: -

Identifier Source: org_study_id