Verteporfin PDT for subfoveal occult CNV in AMD: two-year results of a randomized trial

Curr Med Res Opin. 2009 Aug;25(8):1853-60. doi: 10.1185/03007990903038616.


Objective: To determine whether verteporfin photodynamic therapy (PDT) can safely reduce the risk of vision loss in patients with subfoveal occult with no classic choroidal neovascularization (CNV) due to age-related macular degeneration.

Research design and methods: Eligible patients were > or =50 years of age with lesion size < or =6 disc areas and best-corrected vision 20/40-20/200. A total of 364 patients with occult with no classic CNV were randomly assigned 2 : 1 to verteporfin PDT (n = 244) or placebo (n = 120). The primary outcome measures were loss of > or =15 and > or =30 letters of visual acuity (VA) from baseline at 12 and 24 months.

Clinical trial registration: This study was registered with on 20 July 2005. identifier: NCT00121407.

Results: A total of 37% and 47% of verteporfin-treated patients versus 45% and 53% of placebo recipients lost > or =15 letters of VA at month 12 and month 24, respectively; 16% and 23% of verteporfin-treated patients versus 17% and 25% of placebo recipients lost > or =30 letters at month 12 and month 24, respectively. These differences were not statistically significant. Four (1.6%) verteporfin-treated patients and one placebo patient (who received verteporfin in error) experienced an acute severe VA decrease; all five patients recovered some degree of vision. No unexpected ocular or systemic adverse events were identified.

Conclusions: Verteporfin PDT in the treatment of occult with no classic CNV was safe and well-tolerated. The differences between the two groups in the primary efficacy variables were not significant. Baseline characteristics and patient selection methods may have contributed to the small treatment effect.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Choroidal Neovascularization / drug therapy*
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Humans
  • Male
  • Middle Aged
  • Photochemotherapy*
  • Photosensitizing Agents / administration & dosage
  • Photosensitizing Agents / pharmacology*
  • Photosensitizing Agents / therapeutic use
  • Porphyrins / administration & dosage
  • Porphyrins / pharmacology*
  • Porphyrins / therapeutic use
  • Verteporfin
  • Visual Acuity / drug effects


  • Photosensitizing Agents
  • Porphyrins
  • Verteporfin

Associated data