FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in Exudative Age-related Macular Degeneration

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de la Macula y la Retina
• Collaborator: Centro Medico Teknon
• Treatments: Ranibizumab

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.