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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Exudative Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ranibizumab<br> | Drug: Ranibizumab<br>* 0,5mg intravitreal ranibizumab<br>* Other names: luncentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean VA change | change in ETDRS (early treatment diabetic retinopathy study) letters from baseline to 12 month-visit | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 
| 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 | 12 months | 
| The mean VA | mean VA at 6 and 12 months in ETDRS letters | 6 and 12 months | 
| The median VA | median VA at 6 and 12 months in ETDRS letters | 12 months | 
| The mean number of injections | the mean number of injections administered to patients from baseline to month 12 ( month 12 not included) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, ranibizumab, antiVEGF, regimen of injections, anti VEGF regimen, PRN, treat and extend