September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Intravitreal Aflibercept For Neovascular Polypoidal Choroidal Vasculopathy In A Predominantly Non-Asian Population: 1-Year Rival Trial Results
Author Affiliations & Notes
  • Dennis M Marcus
    Southeast Retina Center, Augusta, Georgia, United States
  • Amina Farooq
    Southeast Retina Center, Augusta, Georgia, United States
  • Heather Frazier
    Southeast Retina Center, Augusta, Georgia, United States
  • Chelsea Fechter
    Southeast Retina Center, Augusta, Georgia, United States
  • William Baker Marcus
    Southeast Retina Center, Augusta, Georgia, United States
  • Harinderjit Singh
    Southeast Retina Center, Augusta, Georgia, United States
  • Footnotes
    Commercial Relationships   Dennis Marcus, Acucela (F), Alcon (F), Alimera (C), Alimera (F), Allergan (F), Chiltern (F), Del Mar (F), Genentech (C), Genentech (F), Neurotech (F), Ophthotech (F), Pfizer (F), Regeneron (C), Regeneron (F), Thrombogenics (C), Thrombogenics (F), Xcovery (F); Amina Farooq, None; Heather Frazier, None; Chelsea Fechter, None; William Marcus, None; Harinderjit Singh, Acucela (F), Alcon (F), Alimera (F), Allergan (F), Chiltern (F), Del Mar (F), Genentech (F), Neurotech (F), Ophthotech (F), Pfizer (F), Regeneron (F), Thrombogenics (F), Xcovery (F)
  • Footnotes
    Support  Investigator Initiated Trial Grant Support provided by Regeneron Pharmaceuticals
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 535. doi:
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      Dennis M Marcus, Amina Farooq, Heather Frazier, Chelsea Fechter, William Baker Marcus, Harinderjit Singh; Intravitreal Aflibercept For Neovascular Polypoidal Choroidal Vasculopathy In A Predominantly Non-Asian Population: 1-Year Rival Trial Results. Invest. Ophthalmol. Vis. Sci. 2016;57(12):535.

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      © ARVO (1962-2015); The Authors (2016-present)

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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.

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