Table 4:

Study Characteristics of PRN Re-treatment Strategies with Ranibizumab or Bevacizumab for n-AMD in RCTs

Study, Author, Year, Country	Study Design and Follow-Up	Sites, Patients, Trial Arms	Maintenance Follow-Up	Re-treatment Criteria
SAILOR, Boyer et al, 2009 (50) United States	Phase III RCT (Cohort 1) and open-label (Cohort 2) 1 year	Cohort 1: 105 sites, 1,169 Ps (0.3 mg), and 1,209 Ps (0.5 mg) Cohort 2: 104 sites, 1,922 Ps RCT Cohort 1: 0.3-mg 3MoLD ranibizumab + PRN vs. 0.5-mg 3MoLD ranibizumab + PRN Cohort 2 with 0.5-mg 1MoLD ranibizumab + PRN	Cohort 1 follow-up visits with OCT, VA ETDRS charts at day 0 and months 3, 6, 9 and 12 Cohort 2 follow-up visits with VA at day 0 and months 6 and 12	Cohort 1 based on 1) BCVA ETDRS letter decrease > 5 compared with highest at any prior visit 2) VA as above or OCT > 100 μm CRT, with IRF or SRF Cohort 2 Re-treatment was at physician's discretion
El-Mollayess et al, 2012 (51) Lebanon and France	Open-label single masked RCT	2 sites, 120 Ps Randomized after a loading dose of 2 monthly injections to either continued fixed dosing every 4–6 weeks or variable dosing 1.25 mg of bevacizumab	At follow-up: slit-lamp examination, dilated fundus examination, and monthly OCT and BCVA	1) Recurrence or presence of any fluid in the macula on OCT 2) CRT increased ≥ 50 μm from lowest value 3) VA loss ≥ 5 letters with OCT evidence of fluid in the macula 4) New macular hemorrhage 5) New area of classic CNV amendment addition 6) appearance of new PED, or increased size in previously stable PED

Abbreviations: BCVA, best corrected visual acuity; CNV, choroid neovascularisation; CRT, central retinal thickness; ETDRS; Early Treatment Diabetic Retinopathy Study; IRF, intraretinal fluid; 1MoLD, 1-month loading dose; 3MoLD, 3-month loading dose; n-AMD, neovascular age-related macular degeneration; OCT, optical coherence tomography; P, patient; PED, pigment epithelium detachment; PRN, pro re nata (as needed); RCT, randomized controlled trial; SRF, subretinal fluid; VA, visual acuity.