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

Table 2 Summary of clinical trials in which aflibercept was evaluated for diabetic macular edema

Trial	Study Name
	Phase 1 study of VEGF trap in patients with DME	DA VINCI	VIVID-Japan	VISTA DME	VIVID-DME	Protocol T
Study type	Interventional	Interventional	Interventional	Interventional	Interventional	Interventional
Study phase	Phase 1	Phase 2	Phase 3	Phase 3	Phase 3	Phase 3
Official title	An exploratory study of the safety, tolerability and biological effect of a single intravitreal administration of VEGF trap eye in patients with DME	A double-masked, randomized, controlled study of the safety, tolerability and biological effect of repeated intravitreal administration of VEGF trap-eye in patients with DME	A randomized, double masked, active controlled, phase III study of the efficacy and safety of repeated doses of intravitreal VEGF trap-eye in subjects with DME	A double-masked, randomized, active-controlled, phase 3 study of the efficacy and safety of intravitreal administration of VEGF trap-eye in patients with DME	An open-label phase III study evaluating the safety and tolerability of repeated doses of intravitreal VEGF trap-eye in Japanese subjects with DME	A comparative effectiveness study of intravitreal aflibercept,bevacizumab and ranibizumab for DME
Study design
Allocation	Non-randomized	Randomized	Randomized	N/A	Randomized	Randomized
Endpoint classification	Safety Study	Safety/Efficacy study	Safety/Efficacy study	Safety/Efficacy study	Safety/Efficacy study	Safety/Efficacy study
Intervention model	Single group assignment	Parallel assignment	Parallel assignment	Single group assignment	Parallel assignment	Parallel assignment
Masking	Open label	Double blind (subject, investigator, outcomes assessor)	Double blind (subject, investigator, outcomes assessor)	Open label	Double blind (subject, investigator, outcomes assessor)	single blind (subject)
Primary purpose	Treatment	Treatment	Treatment	Treatment	Treatment	Treatment
Enrollment	5	219	65	466	406	660
Study period	6 wk	52 wk	48 wk	2 yr	52 wk	2 yr
Recruitment status	Completed	Completed	Recruiting	Active, not recruiting	Active, not recruiting	Active, recruiting
Primary outcome measure	To assess the ocular and systemic safety and tolerability of a single IVT injection of VEGF Trap-eye in patients with DME	Change in BCVA	Adverse event collection	Change from baseline of BCVA in ETDRS letter score	Change from baseline of BCVA in ETDRS letter score	Change in visual acuity from baseline to one year adjusted for baseline visual acuity
Estimated study completion date	Completed	Completed	2013	2014	2015	2016

BCVA: Best corrected visual acuity; DME: Diabetic macular edema; VEGF: Vascular endothelial growth factor; ETDRS: Early treatment diabetic retinopathy study.