FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in Exudative Age-related Macular Degeneration
FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in Exudative Age-related Macular Degeneration
The purpose of this study is to investigate the safety and efficacy of a combined
 fixed-interval and a pro re nata (PRN) regimens of ranibizumab (FUSION regimen) for the
 treatment of exudative age-related macular degeneration (AMD) in patients with good visual
 acuity (VA) at baseline. To establish whether similar efficacy to monthly regimens can be
 achieved with fewer injections, even in patients with good VA.
This is a prospective, open-label, consecutive interventional case series in treatment-naïve
 patients with exudative AMD. A loading phase of 2-3 injections is followed by a
 fixed-interval regimen of injections combined with a pro re nata regimen for 12 months.
 Endpoints include VA, presence of fluid at spectral domain optical coherent tomography
 (SD-OCT), adverse events and number of injections administered.
Inclusion Criteria:

 -  subfoveal or juxtafoveal CNV owing to AMD, defined by fluorescein angiography (FA)

 -  presence on SD-OCT of subretinal or intraretinal fluid associated or not with macular
 edema

 -  Best corrected visual acuity (BCVA) in the study eye between 20/20 and 20/125,
 inclusive

 -  total area of the lesion (including blood, neovascularization and scar/atrophy) of ≤8
 disc areas, of which at least 50% must be active choroidal neovascularization (CNV)
 (defined as the neovascular component of the lesion as defined by FA

 -  all angiographic subtypes [predominantly classic, minimally classic and occult] were
 eligible)

 -  clear ocular media and adequate pupillary dilatation to allow collection of fundus
 photographs and FA of a sufficient quality to be analyzed

 -  intraocular pressure of 21 mmHg or less

 -  and no previous treatment for AMD

 Exclusion Criteria:

 -  presence of scarring or atrophy >75% of the total lesion size (patients with subfoveal
 scar or atrophy were excluded)

 -  subretinal haemorrhage >75% of the total lesion size; presence of serous retinal
 pigment epithelial detachments >5 disc areas

 -  presence of intraocular inflammation (≥ trace cell or flare), epiretinal membrane,
 macular hole or vitreous haemorrhage

 -  history of idiopathic or autoimmune-associated uveitis in either eye

 -  significant media opacities, including cataract, which might interfere with VA,
 assessment of toxicity or fundus photography in the study eye

 -  presence of other causes of CNV, including pathological myopia (spherical equivalent
 of -3 diopters or more, or axial length of 25 mm or more, or fundus findings
 suggestive of pathologic myopia), ocular histoplasmosis syndrome, angioid streaks,
 choroidal rupture and multifocal choroiditis

 -  any retinal treatment (aside from antioxidants), including (but not limited to)
 intravitreal injections, photodynamic therapy with verteporfin, laser photocoagulation
 or surgery

 -  history of rhegmatogenous retinal detachment, pars plana vitrectomy or corneal
 transplant

 -  and previous radiation in the region of the study eye.