Exudative Age-related Macular Degeneration
Conditions
Keywords
AMD, ranibizumab, antiVEGF, regimen of injections, anti VEGF regimen, PRN, treat and extend
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.
Interventions
DRUGRanibizumab
0,5mg intravitreal ranibizumab
Sponsors
Centro Medico Teknon
Institut de la Macula y la Retina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean VA change | 12 months | change in ETDRS (early treatment diabetic retinopathy study) letters from baseline to 12 month-visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS | 12 months | 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 | 12 months | percentage of patients with lost of \<5, \<15 and \<30 ETDRS letters at 12 months compared to baseline |
| The mean VA | 6 and 12 months | mean VA at 6 and 12 months in ETDRS letters |
| The median VA | 12 months | median VA at 6 and 12 months in ETDRS letters |
| The mean number of injections | 12 months | the mean number of injections administered to patients from baseline to month 12 ( month 12 not included) |
Countries
Spain
Outcome results
None listed