• To study the effect of PDT on subfoveal CNV

Method of the study:

• 609 patients with AMD and subfoveal CNV with a classic component and refracted logMAR visual acuity (VA) between 6/12 and 6/60 (Snellen equivalent) underwent a 2:1 randomisation between treatment and control (sham treatment).

• Retreatment was applied to zones of persistent or new leakage at 3 monthly visits. 

Duration of follow-up:

• Follow-up rates were 94% at 12 and 87% at 24 months. 

Results of the study:

• The frequency of stable (<15 logMAR letters lost) or improved vision in each group was: 12 months - 61% treated, 46% placebo (p<0.001); 24 months - 53% treated, 37% placebo (p<0.001). 

• At 12 months a visual improvement (15 letters) occurred in 16% treated and 7% placebo patients. 

 
• For predominantly classic lesions the frequency of stable/improved vision was: 

 
• 12 months - 67% treated, 39% placebo (p<0.001)
• 24 months - 59% treated, 31% placebo (p<0,001).
• For lesions with no occult component frequencies at 12 months were: 73% treated, 23% placebo (p<0.01). 

 
• Treatment benefit was also shown for secondary endpoints. Average number of treatments in the treated group was 5.6 (3.4 in the first 12 months). 

Potential complications:

• There were a similar number of deaths and serious adverse events in each group. 
• <2% of patients were withdrawn due to adverse events. 
• Commoner in treated patients at 12 months were: transient visual disturbance - 18% treated, 12% placebo; injection site events - 13% treated, 0% placebo; transient photosensitivity reactions - 3% treated, 0% placebo; low back pain - 2% treated, 0% placebo. 

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