This is a multicenter, randomized, open-label study. 40 patients will be followed for a period of 12 months. All consented and enrolled patients will receive either 0.5mg or 2.0mg of intravitreal ranibizumab injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
0.5 mg of intravitreal ranibizumab monthly for 12 months
0.5 mg intravitreal injection of ranibizumab for 4 months followed by PRN dosing
2.0mg of intravitreal ranibizumab monthly for 12 months
Jules Stein Eye Institute
Los Angeles, California, United States
Southern California Desert Retina Consultants
Palm Desert, California, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Mean change in Best Corrected Visual Acuity from baseline measured at 4 meters on the ETDRS chart at 12 months.
Time frame: 12 months
Proportion of eyes reaching BCVA greater than or equal to 20/200
Time frame: 12 months
Proportion of eyes gaining greater than or equal to 0, 5, 10, and 15 letters on the ETDRS chart
Time frame: 12 months
Reduction in central macular thickness from baseline (central 1-mm subfield) as measured by an OCT
Time frame: 12 months
Changes in choroidal neovascular lesion (CNV)size on fluorescein angiography and fundus photography from baseline
Time frame: 12 months
Changes in retinal pigment epithelial detachment size on fluorescein angiography and fundus photography, including height of the PED and associated submacular fluid on OCT in comparison to baseline
Time frame: 12 months
Status of fluorescein staining or leakage (increased or decreased) from baseline
Time frame: 12 months
Ocular safety outcome including ocular complication, i.e. RPE tears, uveitis, endophthalmitis
Time frame: 12 months
Systemic safety outcome including cardiovascular event, cerebral vascular events
Time frame: 12 months
Proportion of patients with an improvement from baseline in Contrast Sensitivity at 24 and 48 weeks
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2.0mg of intravitreal injection of Ranibizumab for 4 months followed by PRN dosing
Time frame: 24 and 48 weeks
Proportion of patients with an improvement from baseline in the VFQ overall composite score and near and distance activities subscales at 24 and 48 weeks
Time frame: 24 and 48 weeks