Abstract
Abstract: :
Purpose: To present the 2-year results of the Verteporfin in Ocular Histoplasmosis Syndrome (VOH) Study, which was an open-label, uncontrolled study investigating the safety and effects on visual acuity of verteporfin (Visudyne®, Novartis AG) therapy in patients with subfoveal choroidal neovascularization (CNV) due to the ocular histoplasmosis syndrome (OHS). Methods: At the initial visit, all patients received verteporfin therapy as in the TAP Investigation, and were retreated at 3-monthly follow-up visits if fluorescein leakage from CNV was seen on angiography. Vision outcomes were assessed based on change in visual acuity and contrast sensitivity, and the proportion of patients gaining 7 or more letters, losing at least 8 letters, or losing at least 15 letters of visual acuity. Results: Twenty-five patients with a best-corrected visual acuity letter score of 73-34 (Snellen equivalent approximately 20/40 to 20/200) were enrolled at three centers. Twenty-two (88%) continued to the month 24 examination, at which time 10 (45%) patients gained 7 or more letters (1.4 lines) of visual acuity from baseline. Four (18%) patients lost at least 8 letters (1.6 lines), of which two (9%) lost at least 15 letters (3 lines). Median visual acuity letter score increased by 6.0 letters from baseline. Contrast sensitivity increased by 3 or more letters (at least 0.3 log unit) in 16 patients (73%), and decreased by 3 or more letters in one patient (5%). No treatment-related serious adverse events were reported. Conclusion: These results support the month 12 findings that verteporfin therapy is safe and may be effective for the treatment of subfoveal CNV secondary to OHS.
Keywords: 516 photodynamic therapy • 483 neovascularization • 357 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials