Clinical trial NCT01500915: FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in Exudative Age-related Macular Degeneration
Official title: FUSION Regimen: A Disease Activity Guided Treatment Algorithm With Ranibizumab in naïve Subjects With Exudative Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Exudative Age-related Macular Degeneration
Keywords: AMD
ranibizumab
antiVEGF
regimen of injections
anti VEGF regimen
PRN
treat and extend
Lead sponsor: Institut de la Macula y la Retina
Sponsor class: OTHER
Collaborators: name: Centro Medico Teknon
First posted: 2011-12-29
Enrollment: 17
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: mean VA change
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS
timeFrame: 12 months
measure: The percentage of patients losing <5, <15 and <30 ETDRS letters
timeFrame: 12 months
measure: The mean VA
timeFrame: 6 and 12 months
measure: The median VA
timeFrame: 12 months
measure: The mean number of injections
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de la Macula i de la Retina
Study officials:
affiliation: Institut de la Macula i de la Retina
name: Jordi M Mones, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mones J, Biarnes M, Trindade F, Casaroli-Marano R. FUSION regimen: ranibizumab in treatment-naive patients with exudative age-related macular degeneration and relatively good baseline visual acuity. Graefes Arch Clin Exp Ophthalmol. 2012 Dec;250(12):1737-44. doi: 10.1007/s00417-012-2009-5. Epub 2012 Apr 15.