April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Intravitreal Aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to Presumed Ocular Histoplasmosis Syndrome (POHS): Short-term Results From the HANDLE Study
Author Affiliations & Notes
  • Brian Toussaint
    Retina, Cincinnati Eye Institute/University of Cincinnati, Cincinnati, OH
  • Dennis M Marcus
    Retina, Southeast Retina Center, August, GA
  • Daniel Miller
    Retina, Cincinnati Eye Institute/University of Cincinnati, Cincinnati, OH
  • John W Kitchens
    Retina, Retina Associates of Kentucky, Lexington, KY
  • Harinderjit Singh
    Retina, Southeast Retina Center, August, GA
  • Robert Foster
    Retina, Cincinnati Eye Institute/University of Cincinnati, Cincinnati, OH
  • Michael R Petersen
    Retina, Cincinnati Eye Institute/University of Cincinnati, Cincinnati, OH
  • Robert Sisk
    Retina, Cincinnati Eye Institute/University of Cincinnati, Cincinnati, OH
  • Christopher Riemann
    Retina, Cincinnati Eye Institute/University of Cincinnati, Cincinnati, OH
  • Footnotes
    Commercial Relationships Brian Toussaint, None; Dennis Marcus, Acucela (F), Alcon (F), Allergan (F), Genentech (C), Glaxo Smith Kline (F), LPATH (F), Ophthotech (F), Pfizer (F), Quark (F), Regeneron (C), Thrombogenics (C); Daniel Miller, Alcon (F), Novartis (F), Ophthotech (F), Regeneron (F), Synergetics (C); John Kitchens, Allergan (C), Genentech (C), Regeneron (C), Synergetics (C); Harinderjit Singh, Acucela (F), Alcon (F), Allergan (F), Genentech (F), Glaxo Smith Kline (F), LPATH (F), Ophthotech (F), Pfizer (F), Quark (F), Regeneraon (F), Thrombogenics (F); Robert Foster, Regeneron (F); Michael Petersen, Regeneron (F); Robert Sisk, None; Christopher Riemann, Alcon (C), Genetech (F), Haag Streit USA (C), Johnson and Johnson, Janssen (C), Kaleidoscope Engineering (C), Macor Industries (I), Med One (C), Northmark Pharmacy (I), Salutaris MD (C)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 3923. doi:
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      Brian Toussaint, Dennis M Marcus, Daniel Miller, John W Kitchens, Harinderjit Singh, Robert Foster, Michael R Petersen, Robert Sisk, Christopher Riemann; Intravitreal Aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to Presumed Ocular Histoplasmosis Syndrome (POHS): Short-term Results From the HANDLE Study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3923.

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

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Abstract

Purpose: To report the short-term outcomes of POHS-related CNV to intravitreal aflibercept

Methods: The HANDLE study is an IRB approved open-label, randomized, phase I/II multicenter study evaluating the efficacy, safety, and optimal dosing of intravitreal aflibercept for POHS-related CNV. Forty eyes will be randomized in a 1:1 ratio to two dosing regimens: one aflibercept at randomization followed by monthly PRN dosing for 12 months (PRN Group) or monthly aflibercept for 3 months followed by mandatory aflibercept every 2 months for 12 months (Sustained Group)

Results: Fifteen eyes (8 eyes PRN group and 7 eyes Sustained Group) of the planned 40 eyes have been enrolled to date. Average age of participants is 52 years (19 to 75 years), with 6 caucasian females and 9 caucasian males. Seven, 4, and 4 eyes demonstrated extrafoveal, juxtafoveal, and subfoveal CNV, respectively. At baseline, average visual acuity was 70 letters (48 to 84 letters) with Snellen equivalent of 20/39 (20/20 to 20/125). At baseline, average OCT central subfield thickness (CST) was 383 um (253 to 780 um). All eyes in both groups received aflibercept at baseline. At 1 month follow up there was an average improvement of 7.8 letters (-8 to 19 letters) after receiving 1 aflibercept injection. The average visual acuity was 76.4 letters (66 to 90 letters) with Snellen equivalent of 20/24 (20/16 to 20/50). At 1 month, there was an average thinning of OCT CST of 119.6 um (523 um improvement to 3 um worsening) and the average OCT central subfield thickness was 272.9 um. Three total adverse events were reported (flu, posterior subcapsular cataract, and injection site pain)

Conclusions: Our data shows a favorable short-term safety profile, and response in visual acuity and anatomic changes for the use of aflibercept for POHS-related CNV

Keywords: 453 choroid: neovascularization • 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 688 retina  
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