To assess the safety of intravitreal aflibercept injection in the treatment of proliferative diabetic retinopathy (PDR) by evaluating the incidence and severity of adverse events.
* Single center, open label pilot study using 2.0mg intravitreal aflibercept injection. (IAI) * 20 subjects with active PDR to be randomized into 2 groups, i.e. groups A and B. * Subjects in both arms will be followed-up every 4 weeks until week 52. * The primary endpoint of the study will be at week 52.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
EYLEA (aflibercept) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells.
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Incidence and severity of adverse events of intravitreal aflibercept injection in the treatment of PDR.
Time frame: The primary endpoint of the study will be at week 52.
Mean change in the area of fluorescein leakage in mm2 (area of neovascularization) compared to baseline.
Time frame: At Weeks 24 and 52
Proportion of subjects with complete regression of neovascularization
Time frame: At Weeks 24 and 52
Mean change in ETDRS BCVA from baseline
Time frame: At Weeks 24 and 52
Proportion of subjects gaining > 5 letters, > 10 letters and > 15 letters from baseline
Time frame: At Weeks 24 and 52
Proportion of subjects losing > 5 letters from baseline
Time frame: At Weeks 24 and 52
Mean change in retinal thickness from baseline as demonstrated by Spectral Domain OCT Imaging
Time frame: At Weeks 24 and 52
Proportion of subjects without vitreous hemorrhage or pre-retinal hemorrhage
Time frame: At Weeks 24 and 52
Proportion of subjects with complete avoidance of panretinal laser photocoagulation (PRP)/ additional PRP
Time frame: At Weeks 24 and 52
Proportion of subjects with avoidance of vitrectomy
Time frame: At Weeks 24 and 52
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