Session Title: Free Paper Session 3: AMD I
Session Date/Time: Thursday 07/09/2017 | 08:30-10:00
Paper Time: 09:12
Venue: Room 118
First Author: : H.Agostini GERMANY
Co Author(s): : C. Dahlke F. Holz S. Liakopoulos B. Seitz K. Lorenz R. Silva
The SALT trial (NCT01958918) was initiated to compare the treatment effect of ranibizumab pro re nata (PRN) versus aflibercept bimonthly regimen on CSRT stability as measured by mean CSRT fluctuations between month 3 and month 6. Evidence from various trials suggested that recurring disease activity adversely affects VA outcomes.
SALT is a 12 month prospective, controlled, open-label, multi-centre, European clinical trial in patients with neovascular age-related macular degeneration (nAMD).
Treatment-naive patients with nAMD were randomized to receive intravitreal injections of either 0.5 mg ranibizumab or 2 mg aflibercept. Aflibercept was injected at three initial monthly visits followed by bimonthly treatment whereas patients in the ranibizumab group were treated with monthly injections until maximum stable best-corrected visual acuity (BCVA) and/or no disease activity on Spectral Domain OCT (SD-OCT) was attained for three consecutive monthly assessments. Automated segmentations on SD-OCT volume scans were manually corrected and CSRT (neurosensory retina + subretinal fluid) was evaluated at monthly visits by a central reading centre, masked for treatment assignment. The primary endpoint was fluctuations of CSRT, defined as the average of the absolute differences of CSRT between consecutive visits from month 3 to 6.
A total of 712 patients were randomized to receive either ranibizumab (n=356) or aflibercept (n=356). 672 patients (94.4%) completed the month 6 visit. Patient demographics and baseline characteristics were comparable between groups. Ranibizumab patients had a higher mean baseline CSRT than aflibercept patients (328 ± 113.9 µm vs 310.3 ± 101.0 µm). Fluctuations of CSRT showed a numerical difference of -4.1 µm between treatment arms (LS Mean ranibizumab: 25.2 ± 2.6 µm vs aflibercept: 29.3 ± 2.6 µm; p=0.19). Predefined analyses of retinal stability when adjusted for baseline CSRT showed a significant difference in fluctuations (-6.6 µm) in favor of ranibizumab (LS Mean ranibizumab: 23.5 ± 2.5 µm vs aflibercept: 30.0 ± 2.6 µm; p=0.031). According to protocol-specified dosing regimens, patients received an average of 4.9 out of a possible 6 and 3.9 out of a possible 4 injections in the ranibizumab and aflibercept groups, with VA gains of 4.5 (median 5.0) and 5.6 (median 5.0) letters at month 6. The number of patients with serious adverse events was comparable in both groups (41 patients (11.5%) in the ranibizumab vs. 43 patients (12.1%) in the aflibercept group).
Greater retinal stability demonstrated by reduced fluctuations in CSRT was observed in patients treated with ranibizumab pro re nata compared with patients treated with aflibercept according to its European label. The presented data demonstrate that baseline CSRT affects CSRT fluctuations.