NCT03892434

Bevacizumab Versus DEX Implant Followed by Bevacizumab in ME Secondary to BRVO

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Yeungnam University College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of sequential therapy with intravitreal dexamethasone implant followed by bevacizumab compared with bevacizumab monotherapy for macular edema (ME) secondary to retinal vein occlusion (RVO).

Detailed description

Retinal vein occlusion is the second most common retinal vessel disease following diabetic retinopathy. It is divided into central retinal vein occlusion and retinal vein occlusion. Visual disturbance resulting from retinal vein occlusion is mainly caused by macular edema, and one of the main mechanisms of macular edema is increased vascular endothelial growth factor. Increased vascular endothelial growth factor is known to cause macular edema by breaking blood retinal barrier and causing leakage. For this reason, intravitreal injection of anti - vascular endothelial growth factors is currently used to treat macular edema due to retinal vein occlusion. Corticosteroid is a different mechanism from anti - vascular endothelial growth factor, and it is the main mechanism to suppress macular edema, to suppress the expression of inflammatory mediators, to block the inflammatory reaction pathway, and to lower the vascular endothelial growth factor concentration in the vitreous body. The dexamethasone implant in the vitreous cavity showed the maximum visual improvement effect during 60 day after one injection, and the effect continued until about 90 days after the injection. The same effect was obtained with a fewer injection times compared to the injection of the anti-vascular endothelial growth factor and a variety of inflammatory. It is also effective in patients who do not respond to anti-vascular endothelial growth factors by effectively inhibiting cytokines and growth factors. However, steroids elevated intraocular pressure, it is limited in repeated use. Intravitreal dexamethasone implantation and anti-vascular endothelial growth factor showed similar early vision improvement. The differences in these anatomical changes may be different in long-term visual prognosis. After 3 doses of loading dose of anti-vascular endothelial growth factor, each group was injected with anti-vascular endothelial growth factor (VEGF) at each recurrence of macular edema and injected with anti-vascular endothelial factor at each macular reattachment after dexamethasone injection. The results of this study are as follows.

Conditions

• Branch Retinal Vein Occlusion With Macular Edema

Interventions

Type	Name	Description
DRUG	Intravitreal bevacizumab and dexamethasone implant Injection	Bevacizumab 1.25mg is injected into the vitreous cavity through the pars plana using 30G needle-attached syringe for branch retinal vein occlusion, and Dexamethasone 0.75mg implant is injected using injector.
DEVICE	Intravitreal dexamethasone implant	Dexamethasone implant insertion using approved kit

Timeline

• Start date: 2019-03-18
• Primary completion: 2019-12-18
• Completion: 2020-06-18
• First posted: 2019-03-27
• Last updated: 2019-03-27

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study
• FDA-regulated device study