摘要
Objective To evaluate the safety, effect on visual function, and fluorescein a ngiographic appearance of subfoveal choroidal neovascularization (CNV) through 2 years after photodynamic therapy with verteporfin (Visudyne; Novartis AG, Basel , Switzerland) in patients with ocular histoplasmosis syndrome (OHS). Design Ope n-label, 3-center, uncontrolled clinical study. Participants Ocular histoplasm osis syndrome patients with subfoveal CNV (N=26) with a greatest linear dimensio n no larger than 5400 μm with classic or occult CNV extending under the geometr ic center of the fovea, and best-corrected visual acuity letter score of approx imately 20/40 to 20/200. Methods The methods were similar to those described in the 1-year results with follow-up examinations every 3 months continuing throu gh the second year. During the second year, additional therapy was recommended i f fluorescein angiography showed leakage at a scheduled visit. Main outcome meas urements Visual function measurements included the changes from baseline in visu al acuity and contrast sensitivity scores. Lesion size and leakage from classic and occult CNV were assessed at month 12 and month 24. Safety assessments also w ere made. Results A 24-month examination was completed in 22 of the 26 enrolled participants (85%). At the 24-month examination, median improvement from base line in visual acuity of the 22 patients evaluated was 6 letters; median contras t sensitivity improved by 3.5 letters. At the 24-month examination, 10 patients (45%) gained 7 or more letters of visual acuity from baseline, whereas 4 patie nts (18%) lost 8 or more letters, including 2 patients (9%) who lost at least 15 letters. There was absence of fluorescein angiographic leakage from classic C NV in 17 of the 20 evaluable lesions (85%), and leakage from occult CNV was abs ent in all eyes. No serious ocular adverse events were reported, and no serious systemic event was considered to be associated with treatment. Conclusions Media n visual acuity improved and fluorescein angiographic leakage decreased after ve rteporfin therapy in this small, uncontrolled clinical study of patients with su bfoveal CNV resulting from OHS. Verteporfin therapy seemed to be relatively safe in these patients. The selected cases feature fluorescein angiographic examples of CNV that are important in determining when to apply verteporfin therapy.
Objective To evaluate the safety, effect on visual function, and fluorescein a ngiographic appearance of subfoveal choroidal neovascularization (CNV) through 2 years after photodynamic therapy with verteporfin (Visudyne; Novartis AG, Basel , Switzerland) in patients with ocular histoplasmosis syndrome (OHS). Design Ope n-label, 3-center, uncontrolled clinical study. Participants Ocular histoplasm osis syndrome patients with subfoveal CNV (N=26) with a greatest linear dimensio n no larger than 5400 μm with classic or occult CNV extending under the geometr ic center of the fovea, and best-corrected visual acuity letter score of approx imately 20/40 to 20/200. Methods The methods were similar to those described in the 1-year results with follow-up examinations every 3 months continuing throu gh the second year. During the second year, additional therapy was recommended i f fluorescein angiography showed leakage at a scheduled visit. Main outcome meas urements Visual function measurements included the changes from baseline in visu al acuity and contrast sensitivity scores. Lesion size and leakage from classic and occult CNV were assessed at month 12 and month 24. Safety assessments also w ere made. Results A 24-month examination was completed in 22 of the 26 enrolled participants (85%). At the 24-month examination, median improvement from base line in visual acuity of the 22 patients evaluated was 6 letters; median contras t sensitivity improved by 3.5 letters. At the 24-month examination, 10 patients (45%) gained 7 or more letters of visual acuity from baseline, whereas 4 patie nts (18%) lost 8 or more letters, including 2 patients (9%) who lost at least 15 letters. There was absence of fluorescein angiographic leakage from classic C NV in 17 of the 20 evaluable lesions (85%), and leakage from occult CNV was abs ent in all eyes. No serious ocular adverse events were reported, and no serious systemic event was considered to be associated with treatment. Conclusions Media n visual acuity improved and fluorescein angiographic leakage decreased after ve rteporfin therapy in this small, uncontrolled clinical study of patients with su bfoveal CNV resulting from OHS. Verteporfin therapy seemed to be relatively safe in these patients. The selected cases feature fluorescein angiographic examples of CNV that are important in determining when to apply verteporfin therapy.
出处
《世界核心医学期刊文摘（眼科学分册）》
2005年第2期54-55,共2页
Digest of the World Core Medical Journals:Ophthalmology
