Abstract
Abstract: :
Purpose: To present 4–year results of an open–label, uncontrolled study, the Verteporfin in Ocular Histoplasmosis (VOH) Study, investigating the long–term safety and visual acuity outcomes of verteporfin (Visudyne®, Novartis AG) therapy in patients with subfoveal CNV due to OHS. Methods: Patients completing 24 months of the VOH Study who could potentially benefit further from verteporfin therapy were enrolled in the extension. Patients received open–label treatment with verteporfin every 3 months up to and including the month 45 visit if angiography detected signs of fluorescein leakage from CNV. Vision outcomes were assessed based on: change from baseline in visual acuity and contrast sensitivity; proportion of patients gaining 7 or more letters of visual acuity; and prevention of at least 8 or 15 letters of visual acuity loss. Results: Of the 22 patients who completed the month 24 examination, 17 enrolled in the extension; 15 (88%) completed the month 48 examination. Patients received a mean of 2.9 treatments through month 9, 1.2 treatments through month 21, 0.2 treatments through month 33, and 0.1 treatments through month 45. The total mean number of treatments received was 4.4. For the 15 patients who completed the month 48 examination, mean visual acuity was 69.5 letters at month 24 and 67.5 letters at month 48; an increase from baseline of 12.6 and 10.6 letters, respectively. At the month 48 examination, 11 patients (73%) gained ≥5 letters of visual acuity and an additional 3 (20%) were prevented from losing up to 15 letters of visual acuity compared with baseline. No patient experienced severe (≥30 letters) vision loss from baseline. In the fourth year of treatment, 1 patient (7%) reported serious adverse events (atrial fibrillation and gastritis), which were not considered to be related to study medication. Two patients withdrew from the study: one requested to leave the study and one was lost to follow–up. Conclusions: These results support the month 24 findings that verteporfin therapy is safe for the treatment of subfoveal CNV due to OHS.
Keywords: choroid: neovascularization • photodynamic therapy