A Randomized, Single-blinded, Multicenter, Phase IV Study to Compare Systemic VEGF Protein Dynamics Following Monthly Intravitreal Injections of 0.5 mg Ranibizumab Versus 2 mg Aflibercept Until Study Week 12 in Patients With Visual Impairment Due to Diabetic Macular Edema
Overview
- Phase
- Phase 4
- Intervention
- Ranibizumab
- Conditions
- Visual Impairment Due to Diabetic Macular Edema
- Sponsor
- Novartis Pharmaceuticals
- Locations
- 1
- Primary Endpoint
- Systemic VEGF-A protein levels
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 1 or Type 2 diabetes mellitus
- •Visual impairment predominantly due to DME.
Exclusion Criteria
- •Stroke or myocardial infarction less than 3 months prior to screening.
- •Presence of uncontrolled systolic blood pressure or diastolic blood pressure
- •Renal failure requiring dialysis or renal transplant or renal insufficiency
- •Untreated diabetes mellitus
- •Use of any systemic anti-VEGF drugs
- •Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening.
- •Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant\* and not practicing a medically approved method of contraception
- •For either eye:
- •Any active periocular or ocular infection or inflammation
- •Uncontrolled glaucoma
Arms & Interventions
Group 1
Monthly intravitreal injections of 0.5 mg ranibizumab
Intervention: Ranibizumab
Group 2
Three monthly intravitreal injections of 2 mg aflibercept followed by three monthly intravitreal injections of 0.5 mg ranibizumab
Intervention: Ranibizumab
Group 2
Three monthly intravitreal injections of 2 mg aflibercept followed by three monthly intravitreal injections of 0.5 mg ranibizumab
Intervention: Aflibercept
Outcomes
Primary Outcomes
Systemic VEGF-A protein levels
Time Frame: From baseline to study week 12
Systemic VEGF-A protein levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept (Area under the curve)
Secondary Outcomes
- Systemic VEGF-A protein levels(From study week 12 to 24)
- Systemic VEGF-A levels(From study week 12 to 24)