The purpose of this study is to evaluate the efficacy and safety of intravitreal aflibercept injection in a population of neovascular AMD patients that have been previously treated with 2.0 mg ranibizumab for persistent PEDs.
A Phase 4 study to evaluate the efficacy and safety of intravitreal aflibercept injection in a population of neovascular AMD patients that have been previously treated with 2.0 mg ranibizumab for persistent PEDs (the ROLL study).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Intravitreal Injection 2mg/0.05mL Aflibercept
Pacific Eye Associates
San Francisco, California, United States
Retina Associates of Kentucky
Lexington, Kentucky, United States
Tennessee Retina, P.C.
Nashville, Tennessee, United States
Proportion of patients with flattening of PED
Time frame: 12 months
Mean Change in Best Corrected Visual Acuity (BCVA)
Time frame: 6 month timepoint and 12 month timepoints
Proportion of patients with flattening of PED
Time frame: 6 months
Proportion of patients with flattening of PED
Time frame: 18 month and 24 month timepoints
Mean number of injections needed
Time frame: 12 month period
Mean change in Optical Coherence Tomography (OCT) central retinal thickness
Time frame: 6 month and 12 month timepoints
Proportion of patients gaining 5 letters or more letters on Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Time frame: 6 month and 12 month timepoint
Mean change in BCVA
Time frame: 18 month and 24 month timepoint
Mean number of injections
Time frame: during year 2
Mean change in OCT central retinal thickness
Time frame: 18 month and 24 month timepoints
Proportion of patients gaining 5 letters or more
Time frame: 18 month and 24 month timepoints
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