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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
0,5mg intravitreal ranibizumab
Institut de la Macula i de la Retina
Barcelona, Spain
mean VA change
change in ETDRS (early treatment diabetic retinopathy study) letters from baseline to 12 month-visit
Time frame: 12 months
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
Time frame: 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
Time frame: 12 months
The mean VA
mean VA at 6 and 12 months in ETDRS letters
Time frame: 6 and 12 months
The median VA
median VA at 6 and 12 months in ETDRS letters
Time frame: 12 months
The mean number of injections
the mean number of injections administered to patients from baseline to month 12 ( month 12 not included)
Time frame: 12 months
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