Ranibizumab for Edema of the mAcula in Diabetes: Protocol 4 With Tocilizumab: The READ-4 Study

Sponsor
University of Nebraska
Study ID
NCT02511067
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Intravenous Infusion of Tocilizumab ( 8.0 mg/kg)
  • Ranibizumab — DRUG
    Intravitreal injection of Ranibizumab (0.3mg)

Study Details

The purpose of this study is to investigate the safety, tolerability and efficacy of Ranibizumab and Tocilizumab alone and in combination in eyes with Diabetic Macular Edema.

Key Dates

Start date
Oct 1, 2016
Status verified
Aug 2023
Primary completion
Oct 5, 2016
Completion
Oct 5, 2016

Study Design

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

Arms

  • Active Comparator: Ranibizumab 0.3 mg
    Mandatory monthly treatments with Intravitreal (IVT) ranibizumab (0.3 mg) starting at Baseline (BL) until Month 6. Starting at Month 6, treatments will be administered on as-needed basis, based on retreatment criteria.
  • Experimental: Tocilizumab (8.0 mg/kg)
    Mandatory monthly Intravenous (IV) infusions with tocilizumab (8.0 mg/kg) starting at Baseline (BL) until Month 6. Starting at Month 6, treatments will be administered on as-needed basis with IVT ranibizumab (0.3 mg), based on the retreatment criteria.
  • Experimental: Tocilizumab (8.0 mg /kg) plus Ranibizumab 0.3 mg
    Mandatory Intravitreal (IVT) ranibizumab 0.3 mg at Baseline (BL) followed with an IV infusion of tocilizumab (8.0 mg/kg) on same day starting at Baseline (BL) until Month 6. Combination treatments (IVT ranibizumab 0.3 mg followed by IV tocilizumab 8.0 mg/kg infusion administered at same visit) will be given every month until Month 6. Starting at Month 6, treatments will continue to be administered on as-needed basis with IVT ranibizumab (0.3 mg), based on retreatment criteria.

Primary Outcome Measure

Adverse Events [ Time Frame: 6 months ]

Related Studies