Status:
COMPLETED
FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in Exudative Age-related Macular Degeneration
Lead Sponsor:
Institut de la Macula y la Retina
Collaborating Sponsors:
Centro Medico Teknon
Conditions:
Exudative Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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-rel...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01500915
Start Date
November 1 2010
End Date
July 1 2012
Last Update
March 24 2015
Active Locations (1)
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1
Institut de la Macula i de la Retina
Barcelona, Spain, 08022