Author: Manuel Saenz De Viteri (Spain)
Co-authors: Sergio Recalde, Patricia Fernandez-Robredo, María Isabel López Galvez, Lluis Arias Barquet, Marta Figueroa, Jose García Arumi
Purpose
To assess the effect of fluid status at baseline (BL) and at the end of the loading phase (ELP) of three different ranibizumab regimens: treat-and-extend (T&E), fixed bimonthly (FBM) injections and pro re nata (PRN); on visual and anatomical outcomes of patients with neovascular age-related macular degeneration (nAMD).
Setting/Venue
This was a post hoc analysis conducted using data obtained from the In‐Eye study (EudraCT trial number 2012‐003431‐37), a prospective 12‐month, three‐armed, multicenter (31 sites in Spain), randomized phase IV clinical trial.
Methods
Patients were randomized 1:1:1 to receive one of the three study regimens: T&E, FBM or PRN. Following a mandatory loading phase of three monthly injections, patients in the PRN treatment regimen underwent monthly follow‐up assessments and received treatment when activity criteria were met. In the T&E regimen, the treatment and follow‐up visits were extended by periods of 2 weeks, if appropriate, up to a maximum of 10 weeks. Disease activity was determined by loss of ≥5 ETDRS letters and/or one of the following criteria: new haemorrhages on fundus examination, persistent or recurrent IRF or SRF on spectral‐domain OCT (SD‐OCT), and leakage from CNV on fluorescein angiography (FA; mandatory at the beginning and at the end of the study). The study included 14 or 15 visits, depending on the treatment regimen. Best-corrected visual acuity (BCVA), the mean change from baseline BCVA (BL BCVA), and the proportion of eyes gaining more than 15 letters or losing more than 5 letters were analysed. Morphological characteristics including the subtype of choroidal neovascular membrane and the development of atrophy and fibrosis were also evaluated.
Results
A total of 270 patients (88.5%) completed the study. Throughout the study, patients with persistent SRF only and those with a dry macula at had signicantly higher BCVA than patients with IRF (alone or in combination with SRF). The presence and localization of fluid provided different visual outcomes depending on the treatment regimen. In patients with a dry macula or SRF, there were no significant differences in the mean change in BCVA among the treatment regimens. In contrast, among patients with persistent IRF, the mean change in BCVA was significantly lower in the BM group. The presence of IRF at BL was significantly associated with the development of fibrosis (OR, 2.43; CI 95%: 1.26–4.66, p = 0.006). Moreover, persistent IRF at ELP also conferred a higher risk fibrosis (odds ratio 1.899, 95% CI 1.02–3.53, p 0.045). In contrast, the presence of SRF at BL significantly decreased the risk of developing fibrosis (OR, 0.369; CI 95%: 0.185–0.738, p = 0.007). The presence of SRF did not have a significant effect in the risk of developing atrophy, while persistence of IRF at LP showed a tendency to increase this risk (OR, 1.80; CI 95%: 0.93–3.46, p = 0.08).
Conlusions
While persistance of SRF is compatible with good visual and anatomical outcomes, IRF leads to worse results in patients with nAMD. Our results suggest that patients with IRF may have better visual outcomes when individualized treatment regimens are used (PRN or T&E) in contrast with a fixed bimonthly regimen
Financial Disclosure
None to diclose
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