Clinical Trial: Macugen for Histoplasmosis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Macugen for Histoplasmosis-An Open-Label, Single-Site, Comparative, Prospective Case Series
Brief Summary: The purpose of this study is to evaluate the safety and effect on visual acuity of Macugen (pegaptanib sodium) in patients with subfoveal choroidal neovascularization (CNV) secondary to the ocular histoplasmosis syndrome (OHS).
Detailed Summary:
Ocular histoplasmosis is a leading cause of severe and irreversible central vision loss in middle-aged adults living in the central and eastern US. OHS has been associated with the fungus Histoplasma capsulatum, a dimorphic soil mold found in 18 to 20 states in the central and eastern US. Annually, approximately 100,000 people are thought to be at risk of vision loss caused by OHS.
This study will include OHS patients with CNV lesions no larger than 5400 microns in greatest linear diameter with classic or occult CNV extending under the geometric center of the FAZ and best-corrected visual acuity letter score between 20/40-20/200. Twenty four patients will be enrolled and the study will have 2 treatment arms with 12 patients each. The first arm will consist of 12 patients who will receive 0.3 mg of Macugen intravitreally every 6 weeks for one year. The second arm will consist of 12 patients who will receive Photodynamic Therapy (PDT) with Visudyne every 3 months for one year.
Sponsor: Barnes Retina Institute
Current Primary Outcome: Visual function measurements, including change from baseline in visual acuity: lesion size: and leakage for one year
Original Primary Outcome: Same as current
Current Secondary Outcome: Patients who gain 7 or more letters or patients who lose 8 or more letters from baseline
Original Secondary Outcome: Same as current
Information By: Barnes Retina Institute
Dates:
Date Received: January 4, 2006
Date Started: February 2006
Date Completion: May 2007
Last Updated: October 25, 2006
Last Verified: October 2006
