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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Institut de la Macula y la Retina.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Centro Medico Teknon
Information provided by (Responsible Party):
Jordi Mones, Institut de la Macula y la Retina
ClinicalTrials.gov Identifier:
NCT01500915
First received: December 14, 2011
Last updated: December 25, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Exudative Age-related Macular Degeneration
Drug: Ranibizumab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut de la Macula y la Retina:

Primary Outcome Measures:
  • mean VA change [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    change in ETDRS (early treatment diabetic retinopathy study) letters from baseline to 12 month-visit


Secondary Outcome Measures:
  • Percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS at 12 months compared to baseline

  • The percentage of patients losing <5, <15 and <30 ETDRS letters [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    percentage of patients with lost of <5, <15 and <30 ETDRS letters at 12 months compared to baseline

  • The mean VA [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
    mean VA at 6 and 12 months in ETDRS letters

  • The median VA [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    median VA at 6 and 12 months in ETDRS letters

  • The mean number of injections [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    the mean number of injections administered to patients from baseline to month 12 ( month 12 not included)


Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ranibizumab Drug: Ranibizumab
0,5mg intravitreal ranibizumab
Other Name: luncentis

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500915

Contacts
Contact: Jordi M Mones, MD +34933933117 jmones@institutmacularetina.com

Locations
Spain
Institut de la Macula i de la Retina Recruiting
Barcelona, Spain, 08022
Contact: Jordi M Mones, MD    +34933933117    jmones@institutmacularetina.com   
Principal Investigator: Jordi M Mones, MD         
Sponsors and Collaborators
Institut de la Macula y la Retina
Centro Medico Teknon
Investigators
Principal Investigator: Jordi M Mones, MD Institut de la Macula i de la Retina
  More Information

No publications provided by Institut de la Macula y la Retina

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jordi Mones, Director, Institut de la Macula y la Retina
ClinicalTrials.gov Identifier: NCT01500915     History of Changes
Other Study ID Numbers: FUSION-001-10-2010
Study First Received: December 14, 2011
Last Updated: December 25, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Institut de la Macula y la Retina:
AMD
ranibizumab
antiVEGF
regimen of injections
anti VEGF regimen
PRN
treat and extend

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 21, 2014