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

Primary Purpose

Exudative Age-related Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
Institut de la Macula y la Retina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exudative Age-related Macular Degeneration focused on measuring AMD, ranibizumab, antiVEGF, regimen of injections, anti VEGF regimen, PRN, treat and extend

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut de la Macula i de la Retina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ranibizumab

Arm Description

Outcomes

Primary Outcome Measures

mean VA change
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
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
percentage of patients with lost of <5, <15 and <30 ETDRS letters at 12 months compared to baseline
The mean VA
mean VA at 6 and 12 months in ETDRS letters
The median VA
median VA at 6 and 12 months in ETDRS letters
The mean number of injections
the mean number of injections administered to patients from baseline to month 12 ( month 12 not included)

Full Information

First Posted
December 14, 2011
Last Updated
March 23, 2015
Sponsor
Institut de la Macula y la Retina
Collaborators
Centro Medico Teknon
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1. Study Identification

Unique Protocol Identification Number
NCT01500915
Brief Title
FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in Exudative Age-related Macular Degeneration
Acronym
FUSION
Official Title
FUSION Regimen: A Disease Activity Guided Treatment Algorithm With Ranibizumab in naïve Subjects With Exudative Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de la Macula y la Retina
Collaborators
Centro Medico Teknon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age-related Macular Degeneration
Keywords
AMD, ranibizumab, antiVEGF, regimen of injections, anti VEGF regimen, PRN, treat and extend

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ranibizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
luncentis
Intervention Description
0,5mg intravitreal ranibizumab
Primary Outcome Measure Information:
Title
mean VA change
Description
change in ETDRS (early treatment diabetic retinopathy study) letters from baseline to 12 month-visit
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS
Description
percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS at 12 months compared to baseline
Time Frame
12 months
Title
The percentage of patients losing <5, <15 and <30 ETDRS letters
Description
percentage of patients with lost of <5, <15 and <30 ETDRS letters at 12 months compared to baseline
Time Frame
12 months
Title
The mean VA
Description
mean VA at 6 and 12 months in ETDRS letters
Time Frame
6 and 12 months
Title
The median VA
Description
median VA at 6 and 12 months in ETDRS letters
Time Frame
12 months
Title
The mean number of injections
Description
the mean number of injections administered to patients from baseline to month 12 ( month 12 not included)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordi M Mones, MD
Organizational Affiliation
Institut de la Macula i de la Retina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de la Macula i de la Retina
City
Barcelona
ZIP/Postal Code
08022
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22527314
Citation
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.
Results Reference
derived

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

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