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Completed

NCT Number: NCT01500915

FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in 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.

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Key information

Conditions

Exudative Age-Related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institut de la Macula i de la Retina

Barcelona, 08022, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ranibizumab

Drug

0,5mg intravitreal ranibizumab

Other names: luncentis

Primary outcomes

  1. mean VA change

    Time frame: 12 months

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

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Institut de la Macula y la Retina

Other

Collaborators

  • Centro Medico Teknon

Registry information

Official study title

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

Acronym: FUSION

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 29, 2011
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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