Vascular endothelial growth factor trap-eye (Aflibercept) for the management of diabetic macular edema

Table 1 Summary of some important trials in which vascular endothelial growth factor antagonists have been evaluated for diabetic macular edema

Trial	Drug name
	Pegaptanib	Bevacizumab	Ranibizumab
Study name	Study to Evaluate safety and tolerability of pegaptanib sodium in patients with diabetic macular edema[39]	BOLT study[23,39]	RESOLVE[40]	READ-2[21,20]	READ-3	RISE[22]	RIDE[22]
Study type/phase	Interventional /phase 3	Interventional /phase 2	Interventional /phase 2	Interventional /phase 2	Interventional /phase 2	Interventional /phase 3	Interventional /phase 3
Number of patients	46	80	151	126	142	377	382
Intervention/study design	0.3 mg injections up to a maximum of 48 wk with a minimum-dosing interval of at least 6 wk	(1) Intravitreal Bevacizumab (2) MLT	(1) 0.3 mg Ranibizumab (2) 0.5 mg Ranibizumab (3) Sham	(1) 0.5 mg ranibizumab (group 1) (2) Focal/grid laser (group 2) (3) 0.5 mg ranibizumab + focal/grid laser (group 3)	(1) 0.5 mg ranibizumab (2) 2 mg ranibizumab	(1) Sham (2) 0.3 mg (3) 0.5 mg	(1) Sham (2) 0.3 mg (3) 0.5 mg
Results	No results available yet	Year 1 endpoint: A median gain of 8 ETDRS letters in the bevacizumab group vs a loss of 0.5 ETDRS letters in the MLT group (P = 0.0002) CMT decreased from 507 ± 145 μm to 378 ± 134 μm (P < 0.001) in the bevacizumab group, whereas it decreased from 481 ± 121 μm to 413 ± 135 μm in the MLT group (P = 0.02)[39] Year 2 endpoint: A Mean gain of 8.6 letters for bevacizumab vs a mean loss of 0.5 letters in the MLT group[23]. A mean reduction of 146 μm in the CMT in the bevacizumab arm vs 118 μm in the MLT arm	A gain of 10.3 ± 9.1 letters with ranibizumab and a loss of 1.4 ± 14.2 letters in the sham group (P < 0.0001) A mean CMT reduction of 194.2± 135.1 μm with ranibizumab and 48.4 ± 153.4 μm with sham (P < 0.0001) A gain of ≥ 10 letters in BCVA from baseline in 60.8% of eyes in the ranibizumab group and 18.4% of eyes in the sham group (P < 0.0001)	The mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6 mo primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24 in group 1, group 2 and group 3 respectively The percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. Mean FTH, defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively	The study has completed Results are being analyzed	Year 2 endpoint: 18.1% of sham patients gained ≥15 letters vs 44.8% of 0.3-mg (P < 0.0001) and 39.2% of 0.5-mg ranibizumab patients (P < 0.001)	12.3% of sham patients vs 33.6% of 0.3-mg patients (P < 0.0001) and 45.7% of 0.5-mg ranibizumab patients (P < 0.0001) gained more than 15 letters

DME: Diabetic macular edema; MLT: Macular laser therapy; FTH: Foveal thickness; BOLT: The intravitreal Bevacizumab or Laser Therapy in the Management of Diabetic Macular Edema; READ: The Ranibizumab for Edema of the mAcula in diabetes; CMT: Central macular thickness.