FUSION regimen: ranibizumab in treatment-naïve patients with exudative age-related macular degeneration and relatively good baseline visual acuity

Abstract

BackgroundTo investigate the safety and efficacy of a combined fixed-interval and pro re nata regimen of ranibizumab (FUSION regimen) for treatment of exudative age-related macular degeneration in patients with good visual acuity at baseline. To establish whether similar efficacy to monthly regimens can be achieved with fewer injections, even in patients with good visual acuity.MethodsThis was a prospective, open-label, consecutive interventional case series in treatment-naïve patients with exudative age-related macular degeneration. The FUSION regimen consists of three phases: 1) a loading phase of two or three injections, depending on presence or absence of choroidal neovascularization activity at first follow-up, 2) administration of one injection on disappearance of exudation, and 3) subsequent administration of two separate injections at intervals 2 months apart, and then an injection every 3 months. Endpoints included visual acuity, presence of fluid, adverse events and number of injections administered.ResultsSeventeen eyes of 17 Caucasian patients were included. Mean patient age was 76 years, and 15 patients were female. Mean baseline visual acuity was 67.5 letters (median 67), with Snellen equivalent 20/50++, ranged between 45 (20/125) and 83 (20/20−−). At 3 months, mean change in best-corrected visual acuity (BCVA) was +2.3 letters (median +9) compared with baseline (p = 0.3). At 6 months, mean change in BCVA was +4.2 letters (median +9) compared with baseline (p = 0.02). At 12 months, one patient had discontinued the study. Mean change in BCVA was 5.6 (median +10) compared with baseline (p = 0.04). No patient lost ≥15 letters, and 14 patients (87.5%) lost <5 letters. The mean number of injections was 6.9. One patient experienced a retinal pigment epithelium tear; no other complications were observed.ConclusionsThe FUSION regimen for ranibizumab has the potential to maintain visual gains achieved during the loading phase, as reported in studies with monthly injections, even in eyes with a relatively good visual acuity at baseline. These 12-month results warrant validation in a larger, randomized controlled trial.

Bimonthly Ranibizumab for Neovascular Age-Related Macular Degeneration

“…Modified PRN strategies or algorithms for retreatments have also been proposed, e.g. 3 systematic monthly intravitreal injections in case of neovascular activity (reinforced PRN) or systematic reinjection every 3 months in the absence of neovascular activity (capped PRN) [17,18]. However, all the PRN strategies require monthly examinations with visual acuity testing, fundus examination or photography, and OCT, which is a burden for patients and physicians.…”

Individualized Therapy with Ranibizumab in Wet Age-Related Macular Degeneration

“…The Fusion regimen combines the PRN approach with fixed injections after certain periods of (apparent) inactivity [ 21 , 22 ]. In the second year of the VIEW study, a similar approach was followed and was termed capped-PRN [ 7 ].…”

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

“…Monés et al [41] proposed an alternative dosing scheme consisting on an initial loading phase of three consecutive monthly injections is given (can be reduced to only two monthly injections if the first treatment achieves a 'dry macula'). Afterwards, a PRN regimen is established until cessation of activity (patients still receive one injection after it).…”