Table 8:
Study Characteristics of Ranibizumab Versus Bevacizumab A-VEGF RCTs for n-AMD
| Study, Author, Year, Country | Study Design and Follow-Up | Sites, Patients, Trial Arms | Maintenance Follow-Up | Re-treatment Criteria |
|---|---|---|---|---|
| CATT, Catt Research Group, 2011, (62;64;65) United States | 4-arm active groups, single-masked multicentre non-inferiority RCT 1–2 years | 44 sites, 1208 Ps 1 MoLD of ranibizumab + M 1MoLD of ranibizumab + PRN 1MoLD of bevacizumab + M 1MoLD of bevacizumab + PRN | Follow-up included: monthly ophthalmologic exams; TD-OCT (PRN only), VA, and FA performed at the investigators’ discretion | 1) Fluid on TD-OCT 2)) new or persistent hemorrhage 3) decreased VA (before previous) 4) dye leakage or FA showing increased lesion size |
| MANTRA, Krebs et al, 2013, (61) Austria | 2-arm active groups double-masked multicentre non-inferiority RCT 1 year | 10 sites, 321 Ps 3MoLD of ranibizumab + PRN 3MoLD of bevacizumab + PRN | Follow-up included monthly study visits with biomicroscopy, IOP, BCVA, OCT, medicine and adverse event check; FA was performed at baseline and at 12 months | 1) VA decreased ≥ 5 letters with OCT or FA evidence of macular fluid 2) CRT increased ≥ 100 μm on OCT 3) new macular hemorrhage 4) new area showing CNV 5) persistent fluid on OCT(> 1 month after injection) |
| IVAN, Chakravarthy et al, 2012, (60) United Kingdom | 4-arm active groups single-masked multicentre non-inferiority RCT 1 year | 23 sites, 628 Ps 3MoLD of ranibizumab + BiM 3MoLD of ranibizumab + PRN 3MoLD of bevacizumab + BiM 3MoLD of bevacizumab + PRN | Follow-up included monthly visits with BCVA, clinical exams, OCT, and fundus photography with FA at baseline and months 12 and 24 | 1) On OCT any SRF, increasing IRF, or fresh blood 2) VA decrease by ≥ 10 letters 3) On FA leakage > 25% lesion circumference or expansion CNV |
| Subramanian et al, 2012, (63) United States | 2-arm active groups double-masked RCT 1 year | 1 site, 28 Ps (Veterans Affairs) 3MoLD of ranibizumab + PRN 3MoLD of bevacizumab + PRN | Follow-up included monthly visits with VA, OCT, and clinical exams | 1) On OCT any qualitative increase in IRF or SRF 2) Worsening VA 3) Increased fluid or hemorrhage leading to FA |
Abbreviations: BCVA, best corrected visual acuity; BiM, bimonthly; CNV; classic neovascularization; CRT, central retinal thickness; FA; fluorescein angiography; IOP, intraocular pressure; IRF, intraretinal fluid; 1MoLD, 1-month loading dose; 3MoLD, 3-month loading dose; M, monthly; OCT, optical coherence tomography; P, patient; PRN, pro re nata (as needed); SRF, subretinal fluid; RCT, randomized controlled trial; TD-OCT, time domain–optical coherence tomography; VA, visual acuity.