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

NCT01500915 | Completed Phase 4

• 1 other identifier: FUSION-001-10-2010
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Exudative Age-related Macular Degeneration

Keywords

AMD; ranibizumab; antiVEGF; regimen of injections; anti VEGF regimen; PRN; treat and extend

Outcome Measures

Primary Outcomes (1)

• mean VA change

  change in ETDRS (early treatment diabetic retinopathy study) letters from baseline to 12 month-visit

  12 months

Secondary Outcomes (5)

• Percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS

  12 months

• The percentage of patients losing <5, <15 and <30 ETDRS letters

  12 months

• The mean VA

  6 and 12 months

• The median VA

  12 months

• The mean number of injections

  12 months

Study Arms (1)

ranibizumab

EXPERIMENTAL

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

0,5mg intravitreal ranibizumab

Also known as: luncentis

ranibizumab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de la Macula y la Retina: lead
• Centro Medico Teknon: collaborator

Study Sites (1)

Institut de la Macula i de la Retina

Barcelona, 08022, Spain

Location

Related Publications (1)

• 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.

  PMID: 22527314 DERIVED

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jordi M Mones, MD

  Institut de la Macula i de la Retina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 29, 2011
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

ES (1)