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


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.


BACKGROUND
This study was registered with ClinicalTrials.gov on 20 July 2005. ClinicalTrials.gov 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.
Kaiser
Peter K
PK
Cole Eye Institute, The Cleveland Clinic Foundation, Cleveland, OH 44195, USA. pkkaiser@aol.com
D000368:Aged; D000369:Aged, 80 and over; D020256:Choroidal Neovascularization / Q000188:drug therapy*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use; D011166:Porphyrins / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use; D000077362:Verteporfin; D014792:Visual Acuity / Q000187:drug effects
D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin