Systemic VEGF Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

NCT02258009 | Withdrawn Phase 4

• 1 other identifier: CRFB002DDE25
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Impairment Due to Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Systemic VEGF-A protein levels

  Systemic VEGF-A protein levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept (Area under the curve)

  From baseline to study week 12

Secondary Outcomes (2)

• Systemic VEGF-A protein levels

  From study week 12 to 24

• Systemic VEGF-A levels

  From study week 12 to 24

Study Arms (2)

Group 1

EXPERIMENTAL

Monthly intravitreal injections of 0.5 mg ranibizumab

Drug: Ranibizumab

Group 2

EXPERIMENTAL

Three monthly intravitreal injections of 2 mg aflibercept followed by three monthly intravitreal injections of 0.5 mg ranibizumab

Drug: Ranibizumab; Drug: Aflibercept

Interventions

Ranibizumab DRUG

0.5 mg intravitreal injections

Also known as: Lucentis

Group 1; Group 2

Aflibercept DRUG

2 mg intravitreal injections

Also known as: Eylea

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or Type 2 diabetes mellitus
• Visual impairment predominantly due to DME.

You may not qualify if:

• 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
• Neovascularization of the iris or neovascular glaucoma
• History of treatment with any anti-angiogenic drugs
• For study eye:
• Atrophy or fibrosis involving the center of the fovea at the time of screening or baseline.
• Cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization or macular edema of any other cause than DME

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Chemnitz, 09113, Germany

Location

MeSH Terms

Interventions

Ranibizumab; aflibercept

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceutical

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 7, 2014
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

DE (1)