Trial | NCT01500915  Report issue

Title

FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in Exudative Age-related Macular Degeneration
FUSION Regimen: A Disease Activity Guided Treatment Algorithm With Ranibizumab in naïve Subjects With Exudative Age-related Macular Degeneration

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    17
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.
Study Started
Nov 30
2010
Primary Completion
Mar 31
2012
Study Completion
Jul 31
2012
Last Update
Mar 24
2015
Estimate

Drug Ranibizumab

0,5mg intravitreal ranibizumab

  • Other names: luncentis

ranibizumab Experimental

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.
No Results Posted