Two-year outcome of an observe-and-plan regimen for neovascular age-related macular degeneration: how to alleviate the clinical burden with maintained functional results

Abstract

Two-year outcome of an observeand-plan regimen for neovascular age-related macular degeneration: how to alleviate the clinical burden with maintained functional results This article has been corrected since advance online publication and a corrigendum is also printed in this issue C Gianniou, A Dirani, W Ferrini, L Marchionno, D Decugis, A Deli, A Ambresin and I Mantel AbstractPurpose The purpose of this study was to report the 2-year outcome of an individually tailored 'observe-and-plan' treatment regimen for neovascular age-related macular degeneration (nAMD), and to investigate its clinical value in terms of functional outcome. This regimen aimed to reduce the clinical burden (visits) by employing individually fixed injection intervals, based on the predictability of an individual's need for retreatment. Methods This prospective case series included 104 patients (115 eyes) with nAMD. Following three loading doses of ranibizumab, the disease recurrence interval was determined in monthly observation visits. Retreatment was applied in a series of three injections with individually fixed intervals (2 weeks shorter than the recurrence interval), combined with periodic adjustment of the intervals. The allowed injection intervals in treatment plans ranged from 1 to 3 months. If there was no recurrence at 3 months, the patient could change to monitoring alone. Results Mean visual acuity (VA) improved by 8.7, 9.7, and 9.2 letters at months 3, 12, and 24, respectively. The mean number of injections was 7.8 and 5.8 during years 1 and 2, respectively, whereas the mean number of ophthalmic examinations was 4.0 and 2.9, respectively. The mean treatment interval (after the loading doses) was 2.0 months during year 1, and 2.2 months during year 2. Conclusion The observe-and-plan regimen significantly improved and maintained VA over the course of 2 years. This favourable functional outcome was achieved with fewer clinic visits compared with other regimens. Therefore, this observe-and-plan regimen has the potential to alleviate the clinical burden of nAMD treatment.

Optimizing the Anti-VEGF Treatment Strategy for Neovascular Age-Related Macular Degeneration: From Clinical Trials to Real-Life Requirements

“…Thus, the excellent and stable functional results over 2 years using the Observe-and-Plan regimen served as clinical validation of the regimen. 20 Although functional validation of the regimen is essential, the main interest of the Observe-and-Plan regimen was to achieve these results with fewer visits and an individualized number of injections, which are the main factors impacting the clinical burden: We found that a mean of four visits after baseline was needed during the first year, and this was reduced further to 2.9 visits during the second year. The mean numbers of injections were 7.8 in the first year (including loading doses) and 5.8 in the second year, which were quite similar to other variable-dosing regimens (Fig.…”

“…2). 9,12,15,20 However, the number of visits was three to four times less than what would be needed in PRN with monthly visits 9 and less than half of what is needed in the Treat-and-Extend regimen (Fig. 2).…”

“…19,20 Although this was not a comparative study, it was able to show that the Observe-and-Plan regimen allowed for maintaining the initial visual benefit over 2 years. While the initial VA improvement is mostly dependent on the tissue potential to recover function under VEGF suppression, the retreatment strategy is the main factor for best possible maintenance of this initial benefit over time.…”

“…First, as we reported for the initial 2-year results, late recurrences after more than 3 months of observations may be aggressive and may sometimes necessitate dramatic shortening of the treatment interval. 20 We therefore recommend careful evaluation and clinical judgment in cases of late recurrence. Second, establishing the treatment plan with several dates and precise intervals requires wellorganized communication and calculation of the correct timing.…”

Current state of therapeutic strategies with ranibizumab in neovascular age-related macular degeneration

“…If there was no recurrence at 3 months, the patient could change to monitoring alone. This approach is based on the highly predictable behaviour of recurrent activity in a certain patient with neovascular AMD [37][38][39].…”