Abstract
Purpose :
Evaluation of anti-VEGF therapy for polypoidal choroidal vasculopathy (PCV) has primarily occurred in Asian patients and little data exist for African-American and Caucasian populations. We performed a prospective, non-randomized clinical trial to evaluate the safety and potential efficacy of intravitreal aflibercept in the treatment of PCV-related CNV in a predominantly non-Asian population.
Methods :
Open-label, prospective, unmasked, non-randomized study enrolled 20 eyes (10 treatment-naive;10 non-naïve) with neovascular PCV from 20 subjects. Eyes received monthly aflibercept 2.0 mg intravitreally for 3 months followed by mandatory aflibercept every 2 months for 1 year. Subjects were evaluated monthly for additional intravitreal aflibercept or rescue treatment if pre-defined criteria were met.
Results :
Eighteen of 20 eyes completed 1 year follow-up. Baseline average visual acuity was 60 (20/63), 64 (20/50), and 56 (20/80) EDTRS letters in the overall, treatment-naïve, and non-naïve groups, respectively. At baseline, average OCT central subfield thickness (CST) was 280 um, 291 um, and 268 um in the overall, treatment-naïve, and non-naïve groups, respectively. Through one year, the overall, treatment-naïve, and non-naïve groups received an average of 6.2, 6.6 and 5.8 out of the 7 mandatory scheduled intravitreal aflibercept injections, respectively. Through one year, the overall, treatment-naïve, and non-naïve groups received an average of 0.65 (range0-4), 0.5 (range 0-2), and 0.8 (range 0-4) out of a maximum of 5 additional PRN intravitreal aflibercept injections, respectively. No eyes required rescue therapy such as photodynamic therapy (PDT). At 1 year, average visual acuity was 69 letters (20/40) with an average gain of 8 letters ( treatment-naïve eyes gained 11 letters; non-naïve eyes gained 5 letters). At 1 year, average OCT CST was 213 um indicating an average thinning of 69 um (treatment- naïve and non-naïve eyes thinned 78 um and 58 um, respectively). No endophthalmitis, retinal tears, detachments, vitreous hemorrhage, or arterial thrombotic events were reported.
Conclusions :
This data indicates favorable visual acuity and anatomic response, as well as safety of intravitreal aflibercept monotherapy for neovascular PCV in a predominantly non-Asian population.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.