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

NCT04304755 | Completed Phase 2

• 1 other identifier: 2019/583
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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).

Conditions

Neovascular Age-related Macular Degeneration

Keywords

zoledronic acid; anti-VEGF; anti-vascular endothelial growth factor; adjuvant therapy; AMD

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in best-corrected visual acuity (BCVA) after 52 weeks.

  To assess the change in best-corrected visual acuity measured by logMAR.

  52 weeks

Secondary Outcomes (6)

• The number of anti-VEGF intravitreal injections given after 52 weeks

  52 weeks

• Number of patients with a change in BCVA of 0.3 logMAR or more after 52 weeks.

  52 weeks

• Proportion of patients with refractory nAMD after 52 weeks.

  52 weeks

• EQ 5D score (ranging from 0-1; 0 designates "perfect health" and NEI-VFQ-25 score (ranging from 0 to 100 where 100 reflects best vision-specific health).

  52 weeks

• Mean change from baseline in Central retinal thickness (CRT) after 52 weeks.

  52 weeks

Study Arms (2)

Investigational Medical Product : Zoledronic acid

EXPERIMENTAL

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

Drug: Zoledronic Acid 5 MG in 5 ML Injection

Placebo: NaCl 0,9%

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Zoledronic Acid 5 MG in 5 ML Injection DRUG

Zoledronic acid

Also known as: ZA

Investigational Medical Product : Zoledronic acid

Placebos DRUG

NaCl 0.9%

Also known as: NaCl

Placebo: NaCl 0,9%

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (2)

Spesialistsenteret Pilestredet Park

Oslo, 0176, Norway

Location

Oslo university hospital, Department of Ophthamology

Oslo, 0407, Norway

Location

MeSH Terms

Interventions

Zoledronic Acid; Injections

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Morten C Moe, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor in Ophthalmology

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: March 11, 2020
• Study Start: October 25, 2021
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

NO (2)