Document Detail

Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: meta-analysis of 2-year safety results in three randomized clinical trials: Treatment Of Age-Related Macular Degeneration With Photodynamic Therapy and Verteporfin In Photodynamic Therapy Study Report no. 4.
MedLine Citation:
PMID:  15076937     Owner:  NLM     Status:  MEDLINE    
PURPOSE: We sought to evaluate the detailed safety profile of photodynamic therapy with verteporfin in patients with subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (ARMD) from the combined analysis of three multicenter, double-masked, placebo-controlled, randomized 24-month clinical trials of similar design (TAP Investigation Studies A and B and the VIP ARMD Trial), and to clarify the adverse reaction information in the current verteporfin product prescription information approved in the United States. METHODS: Nine hundred forty-eight patients were randomly assigned to verteporfin or placebo. Treatment was administered as described in previous reports. All general entry criteria were similar, so systemic safety results were combined for this analysis. Entry criteria for CNV lesion composition and visual acuity in the two TAP Investigation trials was different from those used in the VIP ARMD trial, so ocular safety results for the treated eye were not combined. RESULTS: The percentage of patients who experienced at least one ocular or nonocular adverse event, regardless of relationship to therapy, was similar between the verteporfin and placebo groups (92.3 and 89.1%, respectively, P = 0.114). The overall incidence of study eye adverse events was not significantly different between verteporfin and placebo. The only clinically relevant ocular adverse events reported with higher incidence after verteporfin compared with placebo were visual disturbances (22.1 versus 15.5% in TAP [P = 0.054] and 41.7 and 22.8% in VIP [P < 0.001]). Acute severe visual acuity decrease (defined as a visual acuity letter score decrease of at least 20, equivalent to at least four-line decrease, within 7 days of therapy) occurred in 3 patients treated with verteporfin in the TAP Investigation (0.7%) and 11 in the VIP ARMD trial (4.9%). Systemic adverse events with increased incidence after verteporfin compared with placebo, most of which were transient and mild or moderate, were injection site reactions (13.1 versus 5.6%; P < 0.001), photosensitivity reactions (2.4 versus 0.3%; P = 0.016), and infusion-related back pain (2.4 versus 0%; P = 0.004). No clinically relevant difference was observed between the verteporfin and placebo groups in any other adverse event. CONCLUSION: In 948 ARMD patients, verteporfin therapy had an overall safety profile similar to that for placebo, with a few exceptions. Visual disturbances, including acute severe visual acuity decrease, did not affect the net vision outcome benefits associated with treatment that has been reported previously. This detailed safety profile of verteporfin therapy clarifies the adverse reaction information in the current verteporfin product prescription information.
Mohammad Azab; Mustapha Benchaboune; Kevin J Blinder; Neil M Bressler; Susan B Bressler; Evangelos S Gragoudas; Gary Edd Fish; Yong Hao; Laurie Haynes; Jennifer I Lim; Ugo Menchini; Joan W Miller; Jordi Mones; Michael J Potter; Al Reaves; Philip J Rosenfeld; Andrew Strong; Xiang Yao Su; Jason S Slakter; Ursula Schmidt-Erfurth; John A Sorenson; ;
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Publication Detail:
Type:  Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Retina (Philadelphia, Pa.)     Volume:  24     ISSN:  0275-004X     ISO Abbreviation:  Retina (Philadelphia, Pa.)     Publication Date:  2004 Feb 
Date Detail:
Created Date:  2004-04-12     Completed Date:  2004-05-04     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8309919     Medline TA:  Retina     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1-12     Citation Subset:  IM    
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MeSH Terms
Choroidal Neovascularization / drug therapy*,  etiology
Macular Degeneration / complications,  drug therapy*
Photosensitizing Agents / adverse effects,  therapeutic use*
Porphyrins / adverse effects,  therapeutic use*
Randomized Controlled Trials as Topic
Treatment Outcome
Visual Acuity / drug effects
Reg. No./Substance:
0/Photosensitizing Agents; 0/Porphyrins; 129497-78-5/verteporfin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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