Table 2.
Study | Study design | Year | Sample size (patients) | VA (letters) study eye | CMT (µm) study eye |
---|---|---|---|---|---|
Da Vinci (Phase II)75 | Multicenter, randomized, double masked, active controlled | 2012 | |||
0.5q4 | 44 | 11.0a | −165.4a | ||
2q4 | 44 | 13.1a | −227.4a | ||
2q8 | 42 | 9.7a | −187.8a | ||
2PRN | 45 | 12.0a | −180.3a | ||
Controlb | 44 | 2.5 | −58.4 | ||
VISTA (Phase III)76 | Multicenter, randomized, double masked, active controlled | 2014 | |||
2q4 | 154 | 12.5±9.5a | −185.9±150.7a | ||
2q8 | 151 | 10.7±8.2a | −183.1±153.5a | ||
Controlb | 154 | 0.2±12.5 | −73.3±176.7 | ||
VIVID (Phase III)76 | Multicenter, randomized, double masked, active controlled | 2014 | |||
2q4 | 136 | 10.5±9.5a | −195.0±146.6a | ||
2q8 | 135 | 10.7±9.3a | −192.4±149.9a | ||
Controlb | 132 | 1.2±10.6 | −66.2±139.0 | ||
Protocol T (Phase III)5 | Multicenter, randomized, single masked (subject) | 2015 | |||
2q4 | 224 | 13.3 | −169±138 | ||
Bevacizumab | 218 | 9.7 | −101±121 | ||
Ranibizumab (0.3 mg) | 218 | 11.2 | −147±134 |
Notes:
P<0.05 compared to control arm;
macular laser photocoagulation; 0.5q4–0.5 mg aflibercept; every 4 weeks; 2q4–2 mg aflibercept every 4 weeks; 2q8–2 mg aflibercept every 8 weeks following three loading doses; PRN – aflibercept pro re nata following three loading doses.
Abbreviations: VA, visual acuity; CMT, central macular thickness.