Objective: Guidelines were developed based on best available scientific data as well as consensus of expert opinion in absence of controlled clinical trial data to: 1) assist ophthalmologists with selection of patients for whom photodynamic therapy with verteporfin, termed "verteporfin therapy," should be considered; and 2) offer suggestions regarding treatment, follow-up, and re-treatment.
Methods: Consensus from roundtable of retina specialists who either participated in randomized clinical trials evaluating verteporfin therapy or had clinical experience with verteporfin therapy was based on results of these trials and expert opinion. Additional input and advice were received from representatives on behalf of the Macula Society, the Retina Society, and the Vitreous Society, as well as principal investigators of randomized clinical trials evaluating verteporfin therapy.
Results: Patient selection criteria included the following: 1) in cases due to age-related macular degeneration (AMD), lesion composition either predominantly classic choroidal neovascularization (CNV) or occult with no classic CNV; 2) CNV location subfoveal or so close to the foveal center that conventional laser photocoagulation treatment almost certainly would extend under the center; 3) lesion etiology from AMD, pathologic myopia, or other causes in which the outcome without treatment is likely to be worse than with treatment; 4) vision at a level where further loss would be recognized as detrimental to the quality of life of the patient. Criteria did not include lesion size, except in cases composed of occult with no classic CNV in AMD in which therapy for lesions >4 Macular Photocoagulation Study (MPS) disc areas usually should be considered only when presenting with lower levels of best-corrected visual acuity. Criteria also did not include patient age, history of systemic arterial hypertension, or prior laser photocoagulation. Therapy should occur 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 after any initial or subsequent treatment to determine if there is fluorescein leakage from CNV. Re-treatment should be considered as often as every 3 months if fluorescein leakage from CNV is noted at that time. Re-treatment could be deferred if the biomicroscopic and fluorescein angiographic appearance of the lesion is unchanged and shows minimal 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.
Conclusion: These recommendations provide guidelines on the role of verteporfin therapy in the management of CNV due to AMD and other causes. Revisions of these guidelines may be required as new data become available.