OBJECTIVE: To evaluate the incidence of complications of photodynamic therapy (PDT) with verteporfin in subfoveal choroidal neovascularizations secondary to age-related macular degeneration and pathologic myopia. METHODS: In this retrospective interventional case series, the occurrence of complications after PDT in a clinical setting was analyzed. Consecutive medical records of patients with age-related macular degeneration and pathologic myopia treated with PDT were reviewed for complications. Complications included treatment-related systemic adverse events, injection site effects, and ocular adverse events. RESULTS: We included 273 patients (198 with age-related macular degeneration and 75 with pathologic myopia) in the study. A total of 485 photodynamic treatment sessions were performed. Infusion-related back or chest pain was reported by 6 patients (2.2%; 95% confidence interval [CI], 0.8%-4.7%). Injection site effects, extravasation, and photosensitivity reactions were not observed. Dyspnea and flushing during infusion were observed in 2 patients (0.7%; 95% CI, 0.09%-2.6%). Body pain, shortness of breath, and elevated blood pressure were noted in 13 patients (4.8%; 95% CI, 2.6%-8.0%). General pruritus was described by 6 patients (2.2%; 95% CI, 0.8%-4.7%), starting 4 hours after the infusion of verteporfin, and resolved within 72 hours after PDT. A total of 8 patients (2.9%; 95% CI, 1.3%-5.7%) reported an acute severe visual acuity decrease of at least 4 Early Treatment Diabetic Retinopathy Study lines occurring within 7 days of treatment. CONCLUSIONS: Complications associated with PDT are uncommon, but there were limitations of retrospective studies for identifying safety problems. Complications like acute severe visual events may occur in about 3% of patients. We believe that this risk is outweighed by the benefits of PDT on visual function in most patients.
OBJECTIVE: To evaluate the incidence of complications of photodynamic therapy (PDT) with verteporfin in subfoveal choroidal neovascularizations secondary to age-related macular degeneration and pathologic myopia. METHODS: In this retrospective interventional case series, the occurrence of complications after PDT in a clinical setting was analyzed. Consecutive medical records of patients with age-related macular degeneration and pathologic myopia treated with PDT were reviewed for complications. Complications included treatment-related systemic adverse events, injection site effects, and ocular adverse events. RESULTS: We included 273 patients (198 with age-related macular degeneration and 75 with pathologic myopia) in the study. A total of 485 photodynamic treatment sessions were performed. Infusion-related back or chest pain was reported by 6 patients (2.2%; 95% confidence interval [CI], 0.8%-4.7%). Injection site effects, extravasation, and photosensitivity reactions were not observed. Dyspnea and flushing during infusion were observed in 2 patients (0.7%; 95% CI, 0.09%-2.6%). Body pain, shortness of breath, and elevated blood pressure were noted in 13 patients (4.8%; 95% CI, 2.6%-8.0%). General pruritus was described by 6 patients (2.2%; 95% CI, 0.8%-4.7%), starting 4 hours after the infusion of verteporfin, and resolved within 72 hours after PDT. A total of 8 patients (2.9%; 95% CI, 1.3%-5.7%) reported an acute severe visual acuity decrease of at least 4 Early Treatment Diabetic Retinopathy Study lines occurring within 7 days of treatment. CONCLUSIONS: Complications associated with PDT are uncommon, but there were limitations of retrospective studies for identifying safety problems. Complications like acute severe visual events may occur in about 3% of patients. We believe that this risk is outweighed by the benefits of PDT on visual function in most patients.
Authors: Myrte B Breukink; Susan M Downes; Giuseppe Querques; Elon H C van Dijk; Anneke I den Hollander; Rocio Blanco-Garavito; Jan E E Keunen; Eric H Souied; Robert E MacLaren; Carel B Hoyng; Sascha Fauser; Camiel J F Boon Journal: Trials Date: 2015-09-21 Impact factor: 2.279