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

FUSION Regimen: A Disease Activity Guided Treatment Algorithm With Ranibizumab in naïve Subjects With Exudative Age-related Macular Degeneration

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.

Study Overview

• Status: Completed
• Conditions: Exudative Age-related Macular Degeneration
• Intervention / Treatment: Drug: Ranibizumab

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08022
    • Institut de la Macula i de la Retina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ranibizumab	Drug: Ranibizumab; 0,5mg intravitreal ranibizumab; Other Names: luncentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean VA change	change in ETDRS (early treatment diabetic retinopathy study) letters from baseline to 12 month-visit	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS	percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS at 12 months compared to baseline	12 months
The percentage of patients losing <5, <15 and <30 ETDRS letters	percentage of patients with lost of <5, <15 and <30 ETDRS letters at 12 months compared to baseline	12 months
The mean VA	mean VA at 6 and 12 months in ETDRS letters	6 and 12 months
The median VA	median VA at 6 and 12 months in ETDRS letters	12 months
The mean number of injections	the mean number of injections administered to patients from baseline to month 12 ( month 12 not included)	12 months

Collaborators and Investigators

• Sponsor: Institut de la Macula y la Retina
• Collaborators: Centro Medico Teknon
• Investigators: Principal Investigator: Jordi M Mones, MD, Institut de la Macula i de la Retina

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: December 14, 2011
• First Submitted That Met QC Criteria: December 25, 2011
• First Posted (Estimate): December 29, 2011

Study Record Updates

• Last Update Posted (Estimate): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: AMD; ranibizumab; treat and extend; PRN; antiVEGF; regimen of injections; anti VEGF regimen
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: FUSION-001-10-2010