Clinical Studies:


Summarized by Mrinali Gupta, MD (Retina Associates of Orange County)

Citation: Abraham P, Yue H, Wilson L. Randomized, double-masked sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 2. American Journal of Ophthalmology 2010; 150: 315-324.

Key Points

  • BOLT was a randomized, controlled, clinical trial that evaluated quarterly dosing of ranibizumab 0.3mg or 0.5mg versus sham for choroidal neovascularization (CNV) from age-related macular degeneration (AMD)
  • Ranibizumab 0.3mg and 0.5mg monthly x 3 and then quarterly produced significantly better visual outcomes compared to sham, but the visual outcomes were worse than those previously reported in clinical trials for monthly ranibizumab for AMD
  • Additional visual benefit was attained by switching to monthly ranibizumab injection late in year 2.
  • Delayed switching to ranibizumab in the sham group (at 14 months or later) did not produce significant visual benefit
  • Objective

    To study the efficacy of ranibizumab monthly and then quarterly for AMD


    Phase 3, multicenter, randomized, double-masked, sham-controlled trial


    24 months



Randomized 1:1:1 to

(a) ranibizumab 0.3mg

(b) ranibizumab 0.5mg

(c) sham injection

Treatment - monthly x 3, then q3 months


  1. After ANCHOR/MARINA data, amendment allowed sham group to receive q3mth ranibizumab 0.5mg after the 12 month visit
  2. After the 12-month PIER data, amendment to allow all patients the opportunity to switch to monthly ranibizumab 0.5mg

RESULTS (24 months)

Study population

Treatment results

Visual acuity end-points (24 months)

Angiographic end-points

Crossover of sham group to ranibizumab

*Statistical analysis unable to be performed to compare groups due to small sample sizes*

Rollover to monthly ranibizumab (for all groups)

*Statistical analysis unable to be performed to compare groups due to small sample sizes*