24 Week Study to Compare Systemic VEGF-levels of Ranibizumab and Aflibercept in DME.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02878681
Phase
PHASE4
Status
Withdrawn

Conditions

  • Visual Impairment Due to Diabetic Macular Edema

Eligibility Criteria

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

Interventions

Study Details

The purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF levels in DME patients in a detailed time course.

Key Dates

Start date
Sep 30, 2016
Status verified
Apr 2017
Primary completion
Sep 30, 2017
Completion
Sep 30, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Monthly intravitreal injections of 0.5 mg ranibizumab for six months
  • Experimental: Group 2
    Monthly intravitreal injections of 2 mg aflibercept for the initial three months followed by monthly intravitreal injections of 0.5 mg ranibizumab for the next three months.
  • Experimental: Group 3
    Monthly injections of 2 mg aflibercept for six months

Primary Outcome Measure

Area under the curve (AUC) of VEGF-A levels from baseline to week 24 [ Time Frame: baseline to week 24 ]