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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