Neovascular Age-related Macular Degeneration MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Zoledronsyre Fresenius Kabi 4 mg/5 ml
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administrati
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion 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 worse 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: 1. Lesions comprising more than 50% blood or fibrosis involving the fovea centre 2. Polypoidal choroidal vasculopathy (PCV) - indocyanine green 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) within one year preceding the initial study treatment 6. Bisphosphonate treatment for osteoporosis within ten years preceding the initial study treatment , or any prior bisphosphonate treatment as an adjuvant to cancer therapy 7.Confirmed or suspected active malignancy. 8.Other factors (i.e. lack of cooperation) that, in the opinion of the investigator, can interfere with the study protocol 9.Known or suspected hypersensitivity to any of the trial products 10.Hypocalcemia (total Ca < 2.15 mmol/L) 11. Renal impairment (estimated ClCR < 35 ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficacy and safety of zoledronic acid as systemic adjuvant therapy for neovascular age-related macular degeneration (AMD). ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is mean change in best-corrected visual acuity (BCVA);Timepoint(s) of evaluation of this end point: After 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The number of anti-VEGF intravitreal injections given Number of patients with a change in BCVA of 0.3 logMAR or more Mean change from baseline in central retinal thickness (CRT) Proportion of patients with refractory nAMD EQ 5D (ranging from 0-1; 0 designates “dead” and 1 designates “perfect health) and NEI-VFQ-25 score (ranging from 0 to 100 where 100 reflects best vision-specific health) at 1 year compared to baseline. Proportion of patients experiencing adverse events of special interest (ESI): osteonecrosis of the jaw or atypical femoral fracture, endophthalmitis or orbital, scleral, or serious intraocular inflammation (grade 4 aqueous cells/FLARE). ;Timepoint(s) of evaluation of this end point: assessed after 52 weeks with the exception of disease remission, which will be assessed after 6 months | — |
Countries
Norway
Contacts
Public ContactMorten Carsten Moe
Oslo University Hospital
Outcome results
None listed