Table 1. Summary of the characteristics of the included head-to-head studies.
Study | Country | Enrollment | Intervention | Maximum follow-up (months) | No of patients PRN treated | No of patients monthly treated | PRN treatment schedule | OCT-Typ |
---|---|---|---|---|---|---|---|---|
CATT 2011/12 | USA | 02/08-12/09 | RAB 0.5 mg or BEV 1.25 mg | 12/24 | 598/515* | 587/263* | One lading dose. Thereafter, patients were evaluated for treatment every 4 weeks and were treated when fluid was present on OCT or when new or persistent hemorrhage, decreased visual acuity relative to the previous visit, or dye leakage on FAG was present. Patients received 1 injection each time they met the retreatment criteria. | TD-OCT or SD-OCT** |
HARBOR 2013/14 | USA | 03/08-10/10 | RAB 0.5 mg | 12/24 | 275 | 274 | Three consecutive monthly loading doses. Thereafter, patients were evaluated every 4 weeks and treated when BCVA decreased by ≥5 letters compared to the previous visit or if there was any evidence of disease activity on SD-OCT. Patients received 1 injection each time they met the retreatment criteria. | SD-OCT |
IVAN 2012/13 | UK | 03/08-10/10 | RAB 0.5 mg or BEV 1.25 mg | 12/24 | 302/258 | 308/259 | Three consecutive monthly loading doses. Thereafter, patients were evaluated for treatment every 4 weeks and were treated when any subretinal fluid, intraretinal fluid, or fresh blood was visible. Also, if there was uncertainty about these criteria and visual acuity dropped by ≥ 10 letters. In the absence of fluid or visual acuity deterioration, fluorescein leakage >25% of the lesion circumference or expansion of CNV was required to initiate retreatment. Patients received 3 monthly injecions each time they met the retreatment criteria. | TD-OCT |
BCVA = best corrected visual acuity; CATT = comparison of age related macular degeneration treatment trials; HARBOR = the phase III, double-masked, multicenter, randomized active treatment-controlled study of the efficacy and safety of 0,5 mg and 2,0 mg ranibizumab administered monthly or on an as-needed basis in patients with subfoveal neovascular age-related macular degeneration; IVAN = inhibit VEGF in age related choroidal neovascularisation; OCT = optical coherence tomography; PRN = pro re nata; SD = spectral domain, TD = time domain.
*In CATT, patients were assigned equally to 1 of 4 treatment groups defined by drug (ranibizumab or bevacizumab) and by dosing regimen at enrollment. At 1 year, patients initially assigned to monthly treatment retained their drug assignment but were reassigned randomly, with equal probability, to either monthly or PRN treatment. Patients initially assigned to PRN had no change in assignment.
**22.6% of the scans in the 2nd year with SD-OCT.