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

Abstract

Background: To 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.

Methods: This 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.

Results: Seventeen 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.

Conclusions: The 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.

Trial registration: ClinicalTrials.gov NCT01500915.

Figures

Fig. 1

Summary of mean BCVA change from baseline over time in patients treated with ranibizumab. Clinical trial results shown were achieved with various ranibizumab treatment regimens [17]. (Reproduced with permission from Ophthalmologica)

Fig. 2

The FUSION regimen: patients are treated by a combination of PRN and fixed-dose injections according to lesion activity. Five examples of the FUSION regimen are represented in the figure [17]. (Reproduced with permission from Ophthalmologica)

Fig. 3

Change in visual acuity from month 3 to month 6 and from month 3 to month 12 in the different trials. Only MARINA, ANCHOR, PrONTO, Dadgostar and FUSION showed a positive change from month 3 to month 6. Only MARINA, ANCHOR and FUSION showed a positive change from month 3 to month 12, despite the mean visual acuity at baseline in FUSION being 10–20 letters higher than in these studies

Fig. 4

Mean change from baseline in visual acuity observed in the different studies. Despite the high level of visual acuity at baseline in the FUSION series, mean visual acuity gain is obtained at 3, 6, and 12 months