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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01500915
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : March 24, 2015
Centro Medico Teknon
Information provided by (Responsible Party):
Jordi Mones, Institut de la Macula y la Retina

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.

Condition or disease Intervention/treatment Phase
Exudative Age-related Macular Degeneration Drug: Ranibizumab Phase 4

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  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FUSION Regimen: A Disease Activity Guided Treatment Algorithm With Ranibizumab in naïve Subjects With Exudative Age-related Macular Degeneration
Study Start Date : November 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ranibizumab Drug: Ranibizumab
0,5mg intravitreal ranibizumab
Other Name: luncentis

Primary Outcome Measures :
  1. mean VA change [ Time Frame: 12 months ]
    change in ETDRS (early treatment diabetic retinopathy study) letters from baseline to 12 month-visit

Secondary Outcome Measures :
  1. Percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS [ Time Frame: 12 months ]
    percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS at 12 months compared to baseline

  2. The percentage of patients losing <5, <15 and <30 ETDRS letters [ Time Frame: 12 months ]
    percentage of patients with lost of <5, <15 and <30 ETDRS letters at 12 months compared to baseline

  3. The mean VA [ Time Frame: 6 and 12 months ]
    mean VA at 6 and 12 months in ETDRS letters

  4. The median VA [ Time Frame: 12 months ]
    median VA at 6 and 12 months in ETDRS letters

  5. The mean number of injections [ Time Frame: 12 months ]
    the mean number of injections administered to patients from baseline to month 12 ( month 12 not included)

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01500915

Institut de la Macula i de la Retina
Barcelona, Spain, 08022
Sponsors and Collaborators
Institut de la Macula y la Retina
Centro Medico Teknon
Principal Investigator: Jordi M Mones, MD Institut de la Macula i de la Retina

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jordi Mones, Director, Institut de la Macula y la Retina Identifier: NCT01500915     History of Changes
Other Study ID Numbers: FUSION-001-10-2010
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by Jordi Mones, Institut de la Macula y la Retina:
regimen of injections
anti VEGF regimen
treat and extend

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents