Prospective Trial of Treat and Extend Aflibercept for Macular Edema Secondary to Branch Retinal Vein Occlusion

Sponsor
Yeungnam University College of Medicine
Study ID
NCT03405376
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 aflibercept injection — DRUG
    Aflibercept 2mg is injected into the vitreous cavity through the pars plana using 30G needle-attached syringe for branch retinal vein occlusion.

Study Details

The purpose of this study is to evaluate the efficacy and safety of the treat-and-extend regimen extending to 4 months by intervals of 4 weeks using intravitreal aflivercept injection for treatment of macular edema secondary to BRVO.

Key Dates

Start date
Jan 25, 2018
Status verified
Jan 2019
Primary completion
Mar 31, 2019
Completion
Sep 30, 2020

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Branch retinal vein occlusion
    Aflibercept 2mg is injected into the vitreous cavity. Center-involved macular edema secondary to branch retinal vein occlusion for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit)

Primary Outcome Measure

Mean change of best corrected visual acuity [ Time Frame: From baseline to Week 72 ]

Central Contacts