Faculty Bibliography

OBJECTIVE: To explore how baseline lesion composition influenced vision outcomes in patients with age-related macular degeneration (AMD) undergoing photodynamic therapy with verteporfin (Visudyne) for subfoveal choroidal neovascularization (CNV) in the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy Investigation. METHODS: Patients with subfoveal lesions secondary to AMD with evidence of classic CNV were categorized into 2 subgroups based on baseline color photographs and fluorescein angiograms assessed by graders at the Wilmer Photograph Reading Center (The Johns Hopkins University School of Medicine) before any outcome analyses as follows: (1) predominantly classic CNV (area of classic CNV >/=50% of the area of the entire lesion) or (2) minimally classic CNV (area of classic CNV <50% but >0% of the area of the entire lesion). Additional exploratory analyses were performed in the predominantly classic subgroup to investigate the effects of visual acuity, lesion size, prior laser photocoagulation, phakic status, micronutrient use, and presence of occult CNV on vision outcomes. MAIN OUTCOME MEASURES: Subgroup analyses of vision and fluorescein angiographic outcomes at 1 and 2 years after study enrollment were examined in an intent-to-treat analysis from 2 multicenter, double-masked, placebo-controlled, randomized clinical trials. RESULTS: Compared with patients who had minimally classic CNV, patients with predominantly classic CNV had a worse initial mean visual acuity and smaller lesions and were more likely to have lesions that included blood or blocked fluorescence. When evaluated by treatment assignment and lesion composition, 84% to 88% completed the month 24 examination. In the subgroup with predominantly classic lesions, visual acuity outcomes were consistently better in verteporfin-treated patients. Outcomes for patients with predominantly classic lesions without occult CNV tended to be better than outcomes for patients with predominantly classic lesions with occult CNV, although the former tended to have smaller lesions and lower levels of visual acuity at baseline. Contrast sensitivity and fluorescein angiographic outcomes (total lesion size, progression of classic CNV, and absence of classic CNV) were better in verteporfin-treated patients than in placebo-treated patients in the predominantly classic and the minimally classic CNV subgroups. In patients with predominantly classic CNV, no interaction of the treatment benefit by phakic status, micronutrient use, or prior laser photocoagulation therapy was noted. CONCLUSIONS: Verteporfin therapy can safely reduce the risk of moderate and severe vision loss in patients with subfoveal lesions that are predominantly classic CNV secondary to AMD. While this benefit seemed to be even greater in the absence of occult CNV, the effect may be related to the smaller lesions and worse visual acuity associated with predominantly classic lesions without occult CNV and not solely to the lesion composition itself. These analyses support initial reports that verteporfin therapy should be used to treat patients with AMD who have predominantly classic CNV, with or without occult CNV, but suggest that further investigations should be performed to determine if lesions with a minimally classic composition might benefit when they are smaller and have lower levels of visual acuity

OBJECTIVE: To report vision and safety outcomes from an extension of a 2-year investigation evaluating verteporfin photodynamic therapy in patients with age-related macular degeneration with subfoveal choroidal neovascularization (CNV). DESIGN AND SETTING: Open-label extension of selected patients from 2 multicenter, double-masked, placebo-controlled, randomized clinical trials, the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy (TAP) Investigation, at 22 ophthalmology practices in Europe and North America. PARTICIPANTS: Patients enrolled in the TAP Investigation and followed up for at least 24 months in whom verteporfin therapy to CNV might reduce the risk of further vision loss. METHODS: Before receiving verteporfin therapy in the extension, eligible patients signed a written informed consent form accompanied by an oral consent process approved by local institutional review boards. Methods were similar to those described for 1- and 2-year results, with follow-up examinations beyond 2 years continuing at 3-month intervals with a few exceptions, including that extension patients with fluorescein leakage from CNV were to receive open-label verteporfin therapy irrespective of their original treatment assignment. RESULTS: Of 402 patients in the verteporfin group, 351 (87.3%) completed the month 24 examination; 320 (91.2%) of these enrolled in the extension study. The enrolled participants included 124 (78.0%) of the 159 verteporfin-treated patients with lesions composed of predominantly classic CNV at baseline, of whom 105 (84.7%) completed the month 36 examination. Verteporfin-treated patients with this lesion composition at baseline who participated in the extension study, with or without a month 36 examination, appeared more likely to have a younger age, better level of visual acuity, absence of fluorescein leakage from classic CNV, or no progression of classic CNV beyond the baseline boundaries of the lesion at the month 24 examination compared with those who did not enroll in the extension. For the 105 patients with a predominantly classic baseline lesion composition who completed the month 36 examination, an average of 1.3 treatments were given from the month 24 examination up to, but not including, the month 36 examination. A letter score loss in the study eye of at least 15 from baseline for these patients occurred in 39 (37.5%) at the month 24 examination compared with 44 (41.9%) of these patients at the month 36 examination. Visual acuity changed little from the month 24 examination (mean, -1.9 lines) to the month 36 examination (mean, -2.0 lines) for these eyes. Verteporfin-treated patients had little change in the mean visual acuity lost and few or no additional instances of infusion-related back pain or photosensitivity reactions from month 24 to month 36. Two patients originally assigned to placebo had acute severe vision decrease within 7 days after verteporfin treatment during the extension. One patient originally assigned to verteporfin had acute severe vision decrease after verteporfin treatment of the fellow eye during the extension. CONCLUSIONS: Vision outcomes for verteporfin-treated patients with predominantly classic lesions at baseline remained relatively stable from month 24 to month 36, although only approximately one third of the verteporfin-treated patients originally enrolled with this lesion composition had a month 36 examination. From these results, the TAP Study Group identified no safety concerns to preclude repeating photodynamic therapy with verteporfin. Additional treatment was judged likely to reduce the risk of further vision loss. Caution appears warranted in the absence of comparison with an untreated group during the extension and since not all patients in the TAP Investigation participated in the TAP Extension

OBJECTIVE: To describe a case of a patient with documented genetic mallatia leventinese who developed a classic choroidal neovascular membrane and underwent photodynamic therapy (PDT) with verteporfin (Visudyne; CIBA Vision Corp., Duluth, GA). DESIGN: Interventional case report. INTERVENTION: The patient underwent a complete ophthalmologic evaluation and fluorescein angiography. Photodynamic therapy with verteporfin was performed. MAIN OUTCOME MEASURES: Clinical and angiographic records were analyzed for evidence of changes in visual acuity, clinically evident subretinal fluid and the extent of fluorescein leakage from choroidal neovascularization (CNV). RESULTS: Three weeks after treatment, a fluorescein angiogram showed closure of the neovascular membrane, no evident subretinal fluid was seen, and visual acuity had improved from 20/60- to 20/40. Nine weeks after the application, fluorescein angiography demonstrated a microscopic hyperfluorescent spot at the site of the previously active CNV at which a small area of shallow subretinal fluid was observed, and visual acuity was 20/50. Thirty-four weeks after PDT, visual acuity was 20/60, subretinal fluid resolved, and fluorescein angiography did not show any further changes. CONCLUSIONS: Photodynamic therapy with verteporfin may be considered as a possible treatment in patients with mallatia leventinese who develop classic CNV

PURPOSE: To study the effects of photodynamic therapy (PDT) using verteporfin on the treatment of patients with subfoveal choroidal neovascularization (CNV) secondary to multifocal choroiditis and panuveitis (MCP), an uncommon disorder with no proven forms of therapy. METHODS: A retrospective chart review of seven consecutive patients with subfoveal CNV secondary to MCP treated with PDT using verteporfin was performed. RESULTS: The mean age of the 7 patients (all myopic women) was 41.4 years. A mean of 1.86 treatments was performed, and the mean follow-up time was 10 months. Four of the seven patients were treated unsuccessfully with corticosteroids before referral for PDT. The mean improvement of visual acuity was 0.86 line; 3 patients (42.8%) had an improvement in visual acuity representing at least a halving of their visual angle, while the other 4 patients remained stable. There were no treatment-related side effects. CONCLUSIONS: Although the follow-up time and the number of patients in this study were limited, the use of PDT was associated with stabilization or improvement of visual acuity in patients with subfoveal CNV secondary to MCP. Further study of this treatment modality is indicated

PURPOSE: To study the effects of photodynamic therapy using verteporfin in the treatment of patients with subfoveal polypoidal choroidal vasculopathy (PCV). METHODS: A retrospective chart review of 16 consecutive patients with subfoveal PCV treated with photodynamic therapy using verteporfin was performed. RESULTS: The mean age of the patients involved was 70.5 years. The mean follow-up time was 12 months. The visual acuity improved in 9 (56.3 %), remained the same in 5 (31.3 %), and decreased in 2 (12.5 %). The mean change in visual acuity was an improvement of 2.38 lines, a difference that was highly significant ( = 0.004). The change in visual acuity was negatively correlated with increasing age. The final visual acuity was positively correlated with initial acuity and negatively correlated with age. These results were confirmed by multiple linear regression. No patient had any lasting complication from the treatment. CONCLUSIONS: Subfoveal PCV has no proven method of treatment. Although the follow-up time and the number of patients in this pilot study were limited, the encouraging results and lack of complications suggest that further study is indicated

PURPOSE: To report the effects of photodynamic therapy using verteporfin in the treatment of patients with subfoveal idiopathic choroidal vascularization (CNV). DESIGN: Interventional case series. METHODS: In a retrospective study, eight eyes of eight consecutive patients aged 55 years or younger with subfoveal idiopathic CNV treated with photodynamic therapy using verteporfin were evaluated. Visual acuity was considered to be improved if the visual angle was halved, while acuity was thought to be worse if the visual angle doubled. RESULTS: The eight patients included three men and five women with a mean (+/- SD) age of 34.6 (+/- 9.7) years (range 25-53 years). The mean follow-up time was 13.5 months. At the end of the follow-up period the visual acuity improved in five eyes (62.5%), remained unchanged in one (12.5%), and decreased in two (25%). The mean acuity improvement was 3.6 lines of Snellen acuity by the end of the follow-up period, a change that was statistically significant (P =.027, Wilcoxon signed-rank test). No patient had any complication from the treatment. CONCLUSIONS: There is no widely accepted method for treating subfoveal idiopathic CNV and all previously investigated methods have had a significant number of serious side effects. Although the follow-up time and the number of patients in this pilot study were limited, the encouraging results and lack of complications suggest that further study is indicated

This study evaluates a single, 45-degree fundus image from a non-mydriatic camera for the triage of subjects at risk for diabetic retinopathy. A complete retinal assessment by a retina specialist was the main comparator for the camera. Inter-observer agreements were calculated for the reading of digital images with different grades of retinopathy. Two hundred eyes of 100 consecutive subjects were evaluated as part of the James Bay diabetic retinopathy screening project; 62% of subjects had no retinopathy, 12% had microaneurysms only, 24% had non-proliferative retinopathy, 5% had clinically significant macular edema (CSME), and 2% had proliferative disease (PDR). The Kappa statistic for two independent observers was 0.85 (p < 0.001) for the identification of retinopathy from the digital images. The sensitivity of the digital camera for the evaluation of any retinopathy was 84.4%, for CSME and/or PDR it was over 90%. The use of a single digital retinal image for the evaluation of diabetic retinopathy was performed with a high degree of inter-observer concordance and a high degree of sensitivity