Guidelines for using verteporfin (visudyne) in photodynamic therapy to treat choroidal neovascularization due to age-related macular degeneration and other causes

Abstract

Guidelines originally were published in 2002 based on best available scientific data as well as consensus of expert opinion in the absence of controlled clinical trial data to assist ophthalmologists with selection of patients for whom photodynamic therapy with verteporfin (Visudyne, Novartis AG, Basel, Switzerland), termed "verteporfin therapy," should be considered, and to offer suggestions regarding initial treatment, follow-up, and additional courses of treatment at follow-up. Consensus was based on results of clinical trials and expert opinion. Additional input and advice were received from representatives on behalf of the American Society of Retina Specialists, the Macula Society, and the Retina Society, as well as principal investigators of randomized clinical trials evaluating verteporfin therapy. Since 2002, additional information relevant to clinical care was published in the peer-reviewed literature; therefore, revisions to the originally published guidelines judged warranted are provided here. Patient selection criteria include the following: (1) in cases due to age-related macular degeneration (AMD), lesion composition of (a) predominantly classic choroidal neovascularization (CNV), (b) occult with no classic CNV with presumed recent disease progression, or (c) relatively small minimally classic lesions; (2) CNV location subfoveal or so close to the foveal center that conventional laser photocoagulation treatment almost certainly would extend under the center; (3) etiology of CNV from AMD, pathologic myopia, or other causes in which the outcome without treatment is likely to be worse than with treatment; and (4) vision at a level where further loss would be recognized as detrimental to the quality of life of the patient. Criteria include lesion size for AMD patients with either a minimally classic lesion composition (where treatment usually should be considered only for relatively smaller lesions) or occult with no classic lesions (where treatment usually should be considered for relatively smaller lesions or those >4 Macular Photocoagulation Study disc areas with a relatively lower or poorer best-corrected visual acuity) but not patient age, history of systemic arterial hypertension, or prior laser photocoagulation. Therapy should be initiated ideally within 1 week of the initial fluorescein angiogram on which the clinical decision to treat is based. Patients should return for follow-up at least as often as every 3 months (+/-2 weeks) after any initial or subsequent treatment to determine if there is fluorescein leakage from CNV. Additional courses of treatment should be considered as often as every 3 months (+/-2 weeks) if fluorescein leakage from CNV is noted at that time. Additional courses of treatment could be deferred if the biomicroscopic and fluorescein angiographic appearances of the lesion are unchanged and show minimal fluorescein leakage, especially when there is no subretinal fluid or fluorescein leakage from CNV underlying the center of the foveal avascular zone. Patients should avoid exposure of skin or eyes to direct sunlight or bright indoor light for 48 hours after treatment or until resolution of any swelling or discoloration from extravasation. Follow-up of relatively larger minimally classic lesions and occult with no classic lesions that initially do not undergo therapy appears indicated so therapy can be considered if a predominantly classic lesion develops or, in the case of occult with no classic lesions, if visual acuity declines slightly to a lower (poorer) level without a marked increase in lesion size. Additional revisions of these guidelines may be required as new data become available.