TY - JOUR
T1 - Photodynamic therapy with verteporfin in ocular histoplasmosis
T2 - Uncontrolled, open-label 2-year study
AU - Rosenfeld, Philip J.
AU - Saperstein, David A.
AU - Bressler, Neil M.
AU - Reaves, Troy A.
AU - Sickenberg, Michel
AU - Rosa, Robert H.
AU - Sternberg, Paul
AU - Aaberg, Thomas M.
AU - Aaberg, Thomas M.
N1 - Funding Information:
Dr Sickenberg has been a paid consultant (which also may include travel expenses at meetings or participation in a speakers bureau). Dr Bressler's employer, the Johns Hopkins University, but not Dr Bressler, is paid for consulting services provided by him to Novartis and QLT Inc. The terms of this institutional consulting agreement are being managed by the Johns Hopkins University in accordance with its conflict of interest policies. Drs Rosenfeld and Saperstein have received clinical research grant support from QLT Inc. and from Novartis Ophthalmics and support for scientific presentations at meetings and for travel expenses from Novartis Ophthalmics. Dr Rosa has received clinical research grants from QLT Inc., Vancouver, Canada. Dr Reaves is an employee of Novartis Ophthalmics and has indicated equity ownership of QLT Inc. This study was supported financially by Novartis Ophthalmics AG, Basel, Switzerland, and QLT Inc.
PY - 2004/9
Y1 - 2004/9
N2 - Objective To evaluate the safety, effect on visual function, and fluorescein angiographic 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 Open-label, 3-center, uncontrolled clinical study. Participants Ocular histoplasmosis syndrome patients with subfoveal CNV (N = 26) with a greatest linear dimension no larger than 5400 μm with classic or occult CNV extending under the geometric center of the fovea, and best-corrected visual acuity letter score of approximately 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 through the second year. During the second year, additional therapy was recommended if fluorescein angiography showed leakage at a scheduled visit. Main outcome measurements Visual function measurements included the changes from baseline in visual 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 were made. Results A 24-month examination was completed in 22 of the 26 enrolled participants (85%). At the 24-month examination, median improvement from baseline in visual acuity of the 22 patients evaluated was 6 letters; median contrast 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 patients (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 CNV in 17 of the 20 evaluable lesions (85%), and leakage from occult CNV was absent in all eyes. No serious ocular adverse events were reported, and no serious systemic event was considered to be associated with treatment. Conclusions Median visual acuity improved and fluorescein angiographic leakage decreased after verteporfin therapy in this small, uncontrolled clinical study of patients with subfoveal 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.
AB - Objective To evaluate the safety, effect on visual function, and fluorescein angiographic 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 Open-label, 3-center, uncontrolled clinical study. Participants Ocular histoplasmosis syndrome patients with subfoveal CNV (N = 26) with a greatest linear dimension no larger than 5400 μm with classic or occult CNV extending under the geometric center of the fovea, and best-corrected visual acuity letter score of approximately 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 through the second year. During the second year, additional therapy was recommended if fluorescein angiography showed leakage at a scheduled visit. Main outcome measurements Visual function measurements included the changes from baseline in visual 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 were made. Results A 24-month examination was completed in 22 of the 26 enrolled participants (85%). At the 24-month examination, median improvement from baseline in visual acuity of the 22 patients evaluated was 6 letters; median contrast 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 patients (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 CNV in 17 of the 20 evaluable lesions (85%), and leakage from occult CNV was absent in all eyes. No serious ocular adverse events were reported, and no serious systemic event was considered to be associated with treatment. Conclusions Median visual acuity improved and fluorescein angiographic leakage decreased after verteporfin therapy in this small, uncontrolled clinical study of patients with subfoveal 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.
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U2 - 10.1016/j.ophtha.2004.02.014
DO - 10.1016/j.ophtha.2004.02.014
M3 - Article
C2 - 15350329
AN - SCOPUS:4444295827
SN - 0161-6420
VL - 111
SP - 1725
EP - 1733
JO - Ophthalmology
JF - Ophthalmology
IS - 9
ER -