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

Sponsor
Yeungnam University College of Medicine
Study ID
NCT03892434
Phase
PHASE4
Status
Unknown

Conditions

  • Branch Retinal Vein Occlusion With Macular Edema

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravitreal bevacizumab and dexamethasone implant Injection — DRUG
    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.
  • Intravitreal dexamethasone implant — DEVICE
    Dexamethasone implant insertion using approved kit

Study Details

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).

Key Dates

First listed
Mar 27, 2019
Start date
Mar 18, 2019
Status verified
Mar 2019
Primary completion
Dec 18, 2019
Completion
Jun 18, 2020

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bevacizumab
  • Active Comparator: Dexamethasone

Primary Outcome Measure

Mean change of best corrected visual acuity [ Time Frame: From baseline to Week 24 ]

Central Contacts