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S. Wolf, AMD Faculty; Visual Acuity Gain With Ranibizumab Therapy: Two-Year Data From the Marina, Anchor, and Pier Trials in Patients With Neovascular Amd. Invest. Ophthalmol. Vis. Sci. 2008;49(13):2883.
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To compare the effect of intravitreal ranibizumab monthly versus quarterly injections on average best corrected visual acuity (BCVA) in patients with neovascular age-related macular degeneration (AMD) who were enrolled in three Phase III, randomized, double-masked trials.
MARINA: Patients (n=716) with minimally classic or occult lesions were treated monthly with 0.3mg or 0.5mg ranibizumab for 2 years. ANCHOR: patients (n=423) with predominantly classic lesions were treated either monthly with 0.3mg or 0.5mg ranibizumab or quarterly with verteporfin photodynamic therapy for 2 years. PIER: Patients (n=184) with neovascular AMD were treated with 0.3mg or 0.5mg ranibizumab monthly for the first 3 months then once every 3 months for 2 years. An amendment during the second year of the trial allowed patients to be rolled over from quarterly to monthly dosing regimen. BCVA was assessed using the standard Early Treatment Diabetic Retinopathy Study (ETDRS) chart to measure the proportion of patients who gained VA in letters from baseline.
The ≥ 15 gain in BCVA in the 0.5mg ranibizumab arms were as follows: in the MARINA trial 34% at year one and 33% at year two. In the ANCHOR trial the proportion was 40% and 41%, and in the PIER trial 13% and 8% respectively. At least 6% of patients gained >30 letters at year one.
The proportion of patients treated with ranibizumab 0.5mg monthly or quarterly and who gained ≥ 15 letters was superior compared to the proportion of patients treated with either verteporfin therapy or sham. The proportion of VA gain was lower in the trial using the quarterly treatment regimen. However, in both monthly or quarterly treatment regimen, the proportion of the VA gain was maintained over 2 years of ranibizumab therapy in all three trials.
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