Anti-VEGF antibody for the treatment of predominantly

classic choroidal neovascularisation in AMD (ANCHOR)

by Dr. Hasan Usmani

 

 

Method

 

         Phase III, randomised, multi-centre double-masked active treatment-controlled trial

         Comparing two different doses of Ranibizumab to verteporfin photodynamic therapy (PDT) in treating subfoveal neovascular macular degeneration.

         423 patients in the United States, Europe and Australia

         Randomised 1:1:1 to either PDT plus sham injection or to placebo PDT plus Ranibizumab (0.3 mg or 0.5 mg) monthly for 24 months.

         Fluorescein angiography every three months to determine the need for additional PDT or placebo PDT

 

 

Inclusion criteria

 

         patients with predominantly classic CNV

         VA 6/12 6/96

 

 

Primary endpoint

 

         Proportion of subjects losing less than 15 ETDRS letters at one year.

 

 

Secondary endpoint

 

         Change in VA from baseline

 

 

Results

 

         Maintaining vision: patients losing fewer than 15 letters at 12 months

o        94% in Ranibizumab 0.3 mg vs. 96% in Ranibizumab 0.5 mg vs. 64% in PDT group (p < 0.0001)

         Improving vision: patients gaining 15 letters or more

o        36% (Ranibizumab 0.3 mg) vs. 40% (Ranibizumab 0.5 mg) vs.  6% (PDT) (p < 0.0001)

         Other findings:

o        Average number of letters gained or lost

         9 letters gained (Ranibizumab 0.3 mg) vs. 11 letters gained (Ranibizumab 0.5 mg) vs.  10 letters lost PDT (p< 0.0001)

o        Severe visual loss

         0% Ranibizumab vs.13% PDT

o        Change in leakage on FFA

         Decreased by average 2 disc areas (DA) in Ranibizumab vs.  increased by average 1/3 DA in PDT (p < 0.0001)

 

Adverse events

 

           Endophthalmitis

         0% in 0.3mg Ranibizumab vs. 1.4% in 0.5mg Ranibizumab

 

           Uveitis

           10.2% in 0.3mg Ranibizumab vs.15% in 0.5mg Ranibizumab vs. 2.8% in PDT

 

           Non-ocular vascular events

           2.2.% in 0.3mg Ranibizumab vs. 4.3% in 0.5 mg Ranibizumab vs. 2.1% in PDT

 

 

Further reading

 

         Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1432-1444.

 

 

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