Zoledronic acid as adjuvant therapy in neovascular age-related macular degeneration: a randomised controlled pilot study
Aims To assess the feasibility of a study protocol for a randomised controlled trial of zoledronic acid (ZA) as adjuvant therapy for neovascular age-related macular degeneration (nAMD).Methods In this 1-year, randomised, double-blinded, placebo-controlled pilot study, nAMD patients were allocated 1:...
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BMJ Publishing Group
2024-12-01
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| Series: | BMJ Open Ophthalmology |
| Online Access: | https://bmjophth.bmj.com/content/9/1/e001964.full |
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| author | Øystein Kalsnes Jørstad Morten Carstens Moe Morten Wang Fagerland Yngvil Solheim Husum Erik Fink Eriksen |
| author_facet | Øystein Kalsnes Jørstad Morten Carstens Moe Morten Wang Fagerland Yngvil Solheim Husum Erik Fink Eriksen |
| author_sort | Øystein Kalsnes Jørstad |
| collection | DOAJ |
| description | Aims To assess the feasibility of a study protocol for a randomised controlled trial of zoledronic acid (ZA) as adjuvant therapy for neovascular age-related macular degeneration (nAMD).Methods In this 1-year, randomised, double-blinded, placebo-controlled pilot study, nAMD patients were allocated 1:1 to receive intravenous ZA 5 mg or placebo at baseline and after 6 months in addition to intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy following a treat-and-extend regimen. Bevacizumab was the first-line anti-VEGF drug, but eyes with refractory nAMD were switched to aflibercept. The primary outcome was mean change in best-corrected visual acuity (BCVA).Results 40 participants enrolled in the study, with 20 allocated to each treatment group. 38 participants received both study infusions, and all participants completed the final assessment. Mean (SD) change in BCVA was 7.5 (9.5) letters in the ZA group and −0.5 (11.5) letters in the control group; the between-group difference was 8.0 letters (95% CI: 1.5 to 15.0 letters). There were no between-group differences in mean change in central retinal thickness, refractory nAMD proportion or mean number of injections.Conclusion It is feasible to conduct a randomised controlled trial of ZA as adjuvant therapy for nAMD in terms of recruitment and adherence to the pilot study protocol. We found a possible visual benefit of ZA that is worth further investigation. To clarify the relationship between ZA and the need for intravitreal injections, we recommend amending the protocol by omitting switching of the anti-VEGF drug. Due to the limited sample size of the pilot study, the estimates of treatment effect are not meant to be confirmatory and should be interpreted with caution.Trial registration number 2019-001492-37 (EudraCT), 04304755 (NCT). |
| format | Article |
| id | doaj-art-c1ed3db5fe42434190e24197f7acf27d |
| institution | Kabale University |
| issn | 2397-3269 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open Ophthalmology |
| spelling | doaj-art-c1ed3db5fe42434190e24197f7acf27d2025-02-06T07:35:09ZengBMJ Publishing GroupBMJ Open Ophthalmology2397-32692024-12-019110.1136/bmjophth-2024-001964Zoledronic acid as adjuvant therapy in neovascular age-related macular degeneration: a randomised controlled pilot studyØystein Kalsnes Jørstad0Morten Carstens Moe1Morten Wang Fagerland2Yngvil Solheim Husum3Erik Fink Eriksen4Department of Ophthalmology, Oslo University Hospital, Oslo, NorwayDepartment of Ophthalmology, Oslo University Hospital, Oslo, NorwayCentre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, NorwayDepartment of Ophthalmology, Oslo University Hospital, Oslo, NorwayPilestredet Park Specialist Centre, Oslo, NorwayAims To assess the feasibility of a study protocol for a randomised controlled trial of zoledronic acid (ZA) as adjuvant therapy for neovascular age-related macular degeneration (nAMD).Methods In this 1-year, randomised, double-blinded, placebo-controlled pilot study, nAMD patients were allocated 1:1 to receive intravenous ZA 5 mg or placebo at baseline and after 6 months in addition to intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy following a treat-and-extend regimen. Bevacizumab was the first-line anti-VEGF drug, but eyes with refractory nAMD were switched to aflibercept. The primary outcome was mean change in best-corrected visual acuity (BCVA).Results 40 participants enrolled in the study, with 20 allocated to each treatment group. 38 participants received both study infusions, and all participants completed the final assessment. Mean (SD) change in BCVA was 7.5 (9.5) letters in the ZA group and −0.5 (11.5) letters in the control group; the between-group difference was 8.0 letters (95% CI: 1.5 to 15.0 letters). There were no between-group differences in mean change in central retinal thickness, refractory nAMD proportion or mean number of injections.Conclusion It is feasible to conduct a randomised controlled trial of ZA as adjuvant therapy for nAMD in terms of recruitment and adherence to the pilot study protocol. We found a possible visual benefit of ZA that is worth further investigation. To clarify the relationship between ZA and the need for intravitreal injections, we recommend amending the protocol by omitting switching of the anti-VEGF drug. Due to the limited sample size of the pilot study, the estimates of treatment effect are not meant to be confirmatory and should be interpreted with caution.Trial registration number 2019-001492-37 (EudraCT), 04304755 (NCT).https://bmjophth.bmj.com/content/9/1/e001964.full |
| spellingShingle | Øystein Kalsnes Jørstad Morten Carstens Moe Morten Wang Fagerland Yngvil Solheim Husum Erik Fink Eriksen Zoledronic acid as adjuvant therapy in neovascular age-related macular degeneration: a randomised controlled pilot study BMJ Open Ophthalmology |
| title | Zoledronic acid as adjuvant therapy in neovascular age-related macular degeneration: a randomised controlled pilot study |
| title_full | Zoledronic acid as adjuvant therapy in neovascular age-related macular degeneration: a randomised controlled pilot study |
| title_fullStr | Zoledronic acid as adjuvant therapy in neovascular age-related macular degeneration: a randomised controlled pilot study |
| title_full_unstemmed | Zoledronic acid as adjuvant therapy in neovascular age-related macular degeneration: a randomised controlled pilot study |
| title_short | Zoledronic acid as adjuvant therapy in neovascular age-related macular degeneration: a randomised controlled pilot study |
| title_sort | zoledronic acid as adjuvant therapy in neovascular age related macular degeneration a randomised controlled pilot study |
| url | https://bmjophth.bmj.com/content/9/1/e001964.full |
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