This Article  • Full text  • PDF  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Choroidal Neovascularization  • Macular Degeneration  • Retinal/ Chorioretinal Disorders  • Randomized Controlled Trial  • Articles for Residents  • Alert me on articles by topic  Social Bookmarking   What's this?

2-Year Results of a Randomized Clinical Trial

Visudyne in Minimally Classic Choroidal Neovascularization Study Group^*

Arch Ophthalmol. 2005;123:448-457.

Objective  To compare the treatment effect and safety of photodynamic therapy with verteporfin using a standard (SF) or reduced (RF) light fluence rate with that of placebo therapy in patients with subfoveal minimally classic choroidal neovascularization (CNV) with age-related macular degeneration.

Design  Phase 2, multicenter, double-masked, placebo-controlled, randomized clinical trial.

Setting  Nineteen ophthalmology practices in North America and Europe.

Participants  Patients with initial best-corrected visual acuity of at least 20/250 and a lesion size of no greater than 6 Macular Photocoagulation Study (MPS) disc areas.

Methods  We randomly assigned 117 patients (1:1:1) to verteporfin infusion (6 mg/m²) and light application with an RF rate (300 mW/cm²) for 83 seconds (light dose of 25 J/cm²) or an SF rate (600 mW/cm²) for 83 seconds (light dose of 50 J/cm²) or to placebo infusion with RF or SF. Treatment was repeated every 3 months if the treating physician noted fluorescein leakage from CNV on angiography. Patients in whom a predominantly classic lesion developed could receive open-label standard verteporfin treatment. Best-corrected visual acuity was measured every 3 months, and angiographic changes were assessed by the Photograph Reading Center through the 3-month examination unless an ocular adverse event or conversion to a predominantly classic lesion was identified by an investigator. Safety was assessed throughout the study. All outcomes were on an intent-to-treat basis.

Results  One hundred three (88%) of 117 patients completed the 24-month examination. Twelve (30%) of 40 patients assigned to placebo received open-label standard verteporfin treatment after confirmation of presence of predominantly classic CNV. At month 12, a loss of at least 3 lines of visual acuity occurred in 5 (14%) of 36 eyes assigned to RF and 10 (28%) of 36 eyes assigned to SF, compared with 18 (47%) of 38 eyes assigned to placebo (RF, P = .002; SF, P = .08; RF + SF, P = .004). At month 24, this loss occurred in 9 (26%) of 34 eyes assigned to RF and 17 (53%) of 32 assigned to SF, compared with 23 (62%) of 37 eyes assigned to placebo (RF, P = .003; SF, P = .45; RF + SF, P = .03). Progression to predominantly classic CNV by 24 months was more common in the placebo group (11 [28%] of 39 patients compared with 2 [5%] of 38 in the RF group [P = .007] and 1 [3%] of 37 in the SF group [P = .002]). No unexpected ocular or systemic adverse events were identified. Treatment-related, usually transient visual disturbances were 13% with SF, 10% with placebo, and 5% with RF.

Conclusions  Verteporfin therapy safely reduced the risks of losing at least 15 letters (3 lines) of visual acuity and progression to predominantly classic CNV for at least 2 years in individuals with subfoveal minimally classic lesions due to age-related macular degeneration measuring 6 MPS disc areas or less. Based on the overall evidence available on verteporfin therapy for these lesions, the VIM Study Group would consider recommending verteporfin therapy for relatively small minimally classic lesions similar to those enrolled in the VIM Trial.

*Authors: The Writing Committee served as author for the Visudyne in Minimally Classic Choroidal Neovascularization (VIM) Study Group.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Combination therapy with verteporfin and anti-VEGF agents in neovascular age-related macular degeneration: where do we stand?
Kaiser
Br J Ophthalmol 2010;94:143-145.
FULL TEXT  

A randomised trial of bevacizumab and reduced light dose photodynamic therapy in age-related macular degeneration: the VIA study
Potter et al.
Br J Ophthalmol 2010;94:174-179.
ABSTRACT | FULL TEXT  

Screening Older Adults for Impaired Visual Acuity: A Review of the Evidence for the U.S. Preventive Services Task Force
Chou et al.
ANN INTERN MED 2009;151:44-58.
ABSTRACT | FULL TEXT  

Combination of verteporfin photodynamic therapy and ranibizumab: effects on retinal anatomy, choroidal perfusion and visual function in the protect study
Kiss et al.
Br J Ophthalmol 2008;92:1620-1627.
ABSTRACT | FULL TEXT  

Same-day administration of verteporfin and ranibizumab 0.5 mg in patients with choroidal neovascularisation due to age-related macular degeneration
Schmidt-Erfurth et al.
Br J Ophthalmol 2008;92:1628-1635.
ABSTRACT | FULL TEXT  

Photodynamic therapy with verteporfin for age-related macular degeneration or polypoidal choroidal vasculopathy: comparison of the presence of serous retinal pigment epithelial detachment
Saito et al.
Br J Ophthalmol 2008;92:1642-1647.
ABSTRACT | FULL TEXT  

Reduced fluence versus standard photodynamic therapy in combination with intravitreal triamcinolone: short-term results of a randomised study
Sacu et al.
Br J Ophthalmol 2008;92:1347-1351.
ABSTRACT | FULL TEXT  

Coagulation Gene Predictors of Photodynamic Therapy for Occult Choroidal Neovascularization in Age-Related Macular Degeneration
Parmeggiani et al.
IOVS 2008;49:3100-3106.
ABSTRACT | FULL TEXT  

Photodynamic therapy in the anti-VEGF era
Fine
Br J Ophthalmol 2007;91:707-708.
FULL TEXT  

Angiotensin II Type 1 Receptor-Mediated Inflammation Is Required for Choroidal Neovascularization
Nagai et al.
Arterioscler. Thromb. Vasc. Bio. 2006;26:2252-2259.
ABSTRACT | FULL TEXT  

Evolving European guidance on the medical management of neovascular age related macular degeneration.
Chakravarthy et al.
Br J Ophthalmol 2006;90:1188-1196.
ABSTRACT | FULL TEXT  

Half dose verteporfin PDT for central serous chorioretinopathy
Stewart
Br J Ophthalmol 2006;90:805-806.
FULL TEXT  

Safety enhanced photodynamic therapy with half dose verteporfin for chronic central serous chorioretinopathy: a short term pilot study
Lai et al.
Br J Ophthalmol 2006;90:869-874.
ABSTRACT | FULL TEXT  

Influence of Treatment Parameters on Selectivity of Verteporfin Therapy
Michels et al.
IOVS 2006;47:371-376.
ABSTRACT | FULL TEXT