Clinical Trial: Treatment for Presumed Ocular Histoplasmosis

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Intravitreal Aflibercept Injection for the Treatment of cHoroidAl Neovascularization seconDary to Presumed ocuLar Histoplasmosis syndromE.(the HANDLE Study)

Brief Summary: The purpose of this study is to monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome.

Detailed Summary:
Sponsor: John Kitchens, MD

Current Primary Outcome: ocular and systemic adverse events [ Time Frame: through Month 12 ]

The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12


Original Primary Outcome: Same as current

Current Secondary Outcome: Visual acuity [ Time Frame: Months 3, 6, 9 and 12 ]

  • Mean change in BCVA from Baseline
  • Proportion of subjects gaining >5,10 and 15 letters
  • Proportion of subjects losing >5, 10 and 15 letters


Original Secondary Outcome: Same as current

Information By: Retina Associates of Kentucky

Dates:
Date Received: February 11, 2013
Date Started: March 2013
Date Completion: August 2014
Last Updated: June 13, 2014
Last Verified: June 2014