title: 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.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Azab
authors.forename: Mustapha
authors.initials: M
authors.lastname: Benchaboune
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Blinder
authors.forename: Neil M
authors.initials: NM
authors.lastname: Bressler
authors.forename: Susan B
authors.initials: SB
authors.lastname: Bressler
authors.forename: Evangelos S
authors.initials: ES
authors.lastname: Gragoudas
authors.forename: Gary Edd
authors.initials: GE
authors.lastname: Fish
authors.forename: Yong
authors.initials: Y
authors.lastname: Hao
authors.forename: Laurie
authors.initials: L
authors.lastname: Haynes
authors.forename: Jennifer I
authors.initials: JI
authors.lastname: Lim
authors.forename: Ugo
authors.initials: U
authors.lastname: Menchini
authors.forename: Joan W
authors.initials: JW
authors.lastname: Miller
authors.forename: Jordi
authors.initials: J
authors.lastname: Mones
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Potter
authors.forename: Al
authors.initials: A
authors.lastname: Reaves
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Rosenfeld
authors.forename: Andrew
authors.initials: A
authors.lastname: Strong
authors.forename: Xiang Yao
authors.initials: XY
authors.lastname: Su
authors.forename: Jason S
authors.initials: JS
authors.lastname: Slakter
authors.forename: Ursula
authors.initials: U
authors.lastname: Schmidt-Erfurth
authors.forename: John A
authors.initials: JA
authors.lastname: Sorenson
mesh_terms: D000368:Aged; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008268:Macular Degeneration / Q000150:complications / Q000188:drug therapy*; D008297:Male; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011166:Porphyrins / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012449:Safety; D016896:Treatment Outcome; D000077362:Verteporfin; D014792:Visual Acuity / Q000187:drug effects
chemical_list: D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin