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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Zoledronic acid
NaCl 0.9%
Spesialistsenteret Pilestredet Park
Oslo, Norway
Oslo university hospital, Department of Ophthamology
Oslo, Norway
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.
Time frame: 52 weeks
The number of anti-VEGF intravitreal injections given after 52 weeks
To assess the number of anti-VEGF injections needed during 52 weeks of treatment.
Time frame: 52 weeks
Number of patients with a change in BCVA of 0.3 logMAR or more after 52 weeks.
Number of patients with a change in BCVA of 0.3 logMAR or more after 52 weeks.
Time frame: 52 weeks
Proportion of patients with refractory nAMD after 52 weeks.
Proportion of patients with refractory nAMD after 52 weeks.
Time frame: 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).
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).
Time frame: 52 weeks
Mean change from baseline in Central retinal thickness (CRT) after 52 weeks.
Mean change from baseline in Central retinal thickness (CRT) after 52 weeks.To assess the proportion of patients with a considerable change in visual function
Time frame: 52 weeks
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).
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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).
Time frame: 52 weeks