Evaluation of Treatment of High riSk proLiferative Diabetic retinopathY With Intravitreal Aflibercept injectioN

Sponsor
Valley Retina Institute
Study ID
NCT02630277
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Aflibercept — DRUG
    Intravitreal Aflibercept Injection 2.0 mg

Study Details

To assess the safety and efficacy of intravitreal aflibercept injection in the regression of retinal neovascularization secondary to high-risk PDR. To characterize baseline/post-induction/maintenance levels of proinflammatory mediators in patients with high-risk PDR

Key Dates

Start date
Jan 31, 2016
Status verified
Dec 2015
Primary completion
Jan 31, 2017
Completion
Jun 30, 2017

Study Design

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

Arms

  • Experimental: Arm 1
    1:1 Intravitreal Aflibercept Injection once every 4 weeks
  • Experimental: Arm 2
    Intravitreal of Aflibercept once every 4 weeks for 4 months then as needed (PRN)

Primary Outcome Measure

Assess ocular and non-ocular adverse events [ Time Frame: 12 Months ]

Central Contacts