Choroidal Neovascularization Clinical Trial
Official title:
Macugen for Histoplasmosis-An Open-Label, Single-Site, Comparative, Prospective Case Series
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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