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

NCT ID: NCT01500915

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-07-31

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.

Conditions

Exudative Age-related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ranibizumab

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: DRUG

0,5mg intravitreal ranibizumab

Interventions

Ranibizumab

0,5mg intravitreal ranibizumab

Intervention Type: DRUG

Other Intervention Names

luncentis

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Medico Teknon

OTHER

Sponsor Role: collaborator

Institut de la Macula y la Retina

OTHER

Sponsor Role: lead

Responsible Party

Jordi Mones

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jordi M Mones, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de la Macula i de la Retina

Locations

Institut de la Macula i de la Retina

Barcelona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 22527314 (View on PubMed)

Other Identifiers

FUSION-001-10-2010

Identifier Type: -

Identifier Source: org_study_id