Systemic VEGF Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT02258009
- 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- Withdrawn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
- Ranibizumab — DRUG0.5 mg intravitreal injections
- Aflibercept — DRUG2 mg intravitreal injections
Study Details
The purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF protein levels in DME patients in a detailed time course.
Key Dates
- Start date
- Oct 31, 2015
- Status verified
- Oct 2016
- Primary completion
- Oct 31, 2016
- Completion
- Oct 31, 2016
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Group 1Monthly intravitreal injections of 0.5 mg ranibizumab
- Experimental: Group 2Three monthly intravitreal injections of 2 mg aflibercept followed by three monthly intravitreal injections of 0.5 mg ranibizumab
Primary Outcome Measure
Systemic VEGF-A protein levels [ Time Frame: From baseline to study week 12 ]