Clinical Studies:


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

Citation: Ho AC, Busbee BG, Regillo CD, et al. Twenty-four-month efficacy and safety of 0.5mg or 2.0 ranibizumab in patients with subfoveal neovascular age-related macular degeneration. Ophthalmology 2014; 121: 2181-2192

Key Points

  • The HARBOR trial was a randomized, treatment-controlled trial that compared ranibizumab 0.5mg monthly, x 3 then monthly PRN, 2mg monthly, and 2mg x 3 then monthly PRN for choroidal neovascularization (CNV) from age-related macular degeneration (AMD)
  • There was no significant difference at 24 months in visual outcomes for patients treated with ranibizumab 0.5mg monthly, x 3 then monthly PRN, 2mg monthly, or 2mg x 3 then monthly PRN (PRN treatment criteria was vision decrease or activity on OCT imaging), with a mean treatment interval of 9.9 weeks (0.5mg PRN) or 12.5 weeks (2mg PRN) in the PRN groups.
  • Adverse ocular and non-ocular events, including Antiplatelet Trialists’ Collaboration criteria (APTC), were similar across all groups
  • Objective

    To study the efficacy of ranibizumab 0.5mg vs. 2 mg monthly vs. PRN for age-related macular degeneration (AMD)


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

  • Duration

    24 months



Randomized (stratified by vision (VA ≤ 20/80; VA > 20/80); lesion subtype; study center) 1:1:1:1 to

(a) ranibizumab 0.5mg monthly

(b) ranibizumab 2mg monthly

(c) ranibizumab 0.5mg monthly x 3 then monthly PRN

(d) ranibizumab 2mg monthly x 3 then monthly PRN

Retreatment criteria for PRN group: monthly evaluation and treatment if ≥ 5 letter decrease in vision or disease activity on OCT (IRF, SRF, sub-RPE fluid)

RESULTS (24 months)

Study population:

Visual acuity end-points

# of injections

Anatomic end-points on OCT

Angiographic end-points

Adverse events