Verteporfin in Photodynamic Therapy

A subsequent trial, the Verteporfin in Photodynamic Therapy (VIP), used the same treatment and follow-up protocol as did the TAP study, but it evaluated AMD in subjects with CNVM that was either occult only (with evidence of recent progression or hemorrhage) or... 

Verteporfin in Photodynamic Therapy Smdy Group. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration two-year results of a randomized clinical trial including lesions with occult with no classic choroidal neovascularization—Verteporfin in Photodynamic Therapy Report 2. Am J Ophthalmol 2001 131 541. 

There has been a significant change in the available treatments for exudative AMD. More direct comparison trials of these different modalities are critically needed, particularly of the VEGF inhibitors, plus guidelines to establish which patients benefit most from treatment, similar to those established by the TAP and Verteporfin in Photodynamic Therapy studies. Whether these new agents are used alone, in combination with established therapies, or with newly developing modalities, they represent a new era in treatment, with patients being the beneficiaries of these treatments, which have the potential to stabilize vision loss and improve quality of life and independence for many patients. 

The successful treatment of experimental CNV with verteporfin PDT led to a series of randomized clinical trials which demonstrated a visual benefit of verteporfin PDT for patients with subfoveal CNY. However, this benefit is achieved with multiple retreatments and the rate of vision loss is still substantial. A recent report from the Verteporfin in Photodynamic Therapy group showed that 29% of patients who received PDT for occult subfoveal CNY lost six or more lines of vision after two years and 55% of these patients lost three or more lines of vision (38). Similarly, the TAP Extension Study found that 37.5% of patients with predominantly classic CNY who were treated with verteporfin PDT lost three or more lines of vision after two years (39). 

The efficacy of verteporfin PDT in reducing the risk of vision loss in patients with subfoveal CNV due to AMD was investigated in multicenter, double-masked, placebo-controlled, randomized trials. The Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) study consisted of two identically designed trials conducted in 22 ophthalmology practices in Europe and North America and evaluated PDT for new and recurrent subfoveal CNV with some classic component (8-11). The Verteporfin in Photodynamic Therapy (VIP) study was carried out in 28 practices across Europe and North America and involved patients with only occult CNV or classic CNV with good visual acuity as well as a subset with CNV caused by pathologic myopia (12-14). 

Figure 3 VIP-AMD study. Proportion of eyes with moderate vision loss (>15 letters) at each three-month study visit for patients with occult with no classic CNV treated with verteporfin or placebo. Abbreviations VIP-AMD, Verteporfin in Photodynamic Therapy-Age-Related Macular Degeneration CNV, choroidal neovascularization. Source From Ref. 13.

Abbreviations CNV, choroidal neovascularization VIP, Verteporfin in Photodynamic Therapy. 

Figure 5 VIP-myopia study. Proportion of eyes with vision loss of at least eight letters in verteporfin-treated and placebo groups at each three-month study visit. Abbreviations. VIP, verteporfin in photodynamic therapy. Source From Ref. 14.

Verteporfin in Photodynamic Therapy Study Group. Photodynamic therapy of subfoveal choroidal neovascularization in pathologic myopia with verteporfin. 1-year results of a randomized clinical trial—VIP report no. 1. Ophthalmology 2001 108 841-852. 

Verteporfin Roundtable Participants. Guidelines for using verteporfin (Visudyne) in photodynamic therapy for choroidal neovascularization due to age-related macular degeneration and other causes update. Retina 2005 25 119. 

Photodynamic therapy appears to be a safe procedure. Infrequent complications include reactions at the injection site, transient reduction in vision, and photosensitivity lasting less than 24 hours. No interactions between verteporfin and other medications have been reported. 

Anonymous. Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin one-year results of 2 randomized clinical trials— TAP Report. Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) Smdy Group. Arch Ophthalmol 1999 117 1329. [Erratum appears in Arch Ophthalmol 2000 118 488.]... 

Miller JW, Schmidt-Effurth U, Sickenberg M, et al. Photodynamic therapy with verteporfin for choroidal neovascularization caused by age-related macular degeneration results of a single treatment in a phase 1 and 2 smdy. Arch Ophthalmol 1999 117 1161. 

Reinke MH, Canakis C, Husain D, et al. Verteporfin photodynamic therapy retreatment of normal retina and choroid in the cynomolgus monkey. Ophthalmology 1999 106 1915-1923. 

Terada Y, Michaud NA, Connolly EJ, et al. Enhanced photodynamic therapy using angiostatin with verteporfin PDT in a laser-injury rat model. Invest Ophthalmol Vis Sci 2003 44 1749 (E-Abstract). 

Zacks DN, Ezra E, Terada Y, et al. Verteporfin photodynamic therapy in the rat model of choroidal neovascularization angiographic and histologic characterization. Invest Ophthalmol Vis Sci 2002 43 2384-2391. 

Photodynamic therapy with verteporfin through 24 months of follow-up and treatment in both the TAP and VIP studies appeared quite safe. The treatment was well tolerated with minimal adverse events attributable to treatment. Photosensitivity reactions were rare and lower in incidence in the VIP study (1%) than the TAP study (3%) despite the shorter recommended protection period of 24 hours compared with 48 hours. Allergic reactions were also rare and more frequent in the placebo groups. The only other nonocular adverse event related to treatment was lower back pain during verteporfin infusion, which occurred in a total of 15 people across both studies. 

Kramer M, Miller JW, Michaud N, et al. Liposomal benzoporphyrin derivative verteporfin photodynamic therapy. Selective treatment of choroidal neovascularization in monkeys. Ophthalmology 1996 103 427-438. 

Saperstein DA, Rosenfeld PJ, Bressler NM, et al. Photodynamic therapy of subfoveal choroidal neovascularization with verteporfin in the ocular histoplasmosis syndrome one-year results of an uncontrolled, prospective case series. Ophthalmology 2002 109 1499-1505. 

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