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

Diabetic Macular Edema Clinical Trial

Official title: Evaluation Of the Safety, Tolerability and Efficacy of Ranibizumab and Tocilizumab in Eyes With Diabetic Macular Edema.

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

This study will evaluate the safety of intravenous (IV) infusions of Tocilizumab in the treatment of subjects with diabetic macular edema (DME) as monotherapy and in combination with intravitreal (IVT) Ranibizumab. It will also evaluate the percentage change in central retinal thickness (CRT) from baseline (BL) to Month 6 in the study eye as assessed by spectral-domain optical coherence tomography (SD-OCT). Other study objectives are to determine: the change in visual acuity (VA) from baseline to Months 3, 6 and 12, the change in CRT from baseline to Months 3, 6 and 12 in all the three treatment arms and determine the number of eyes requiring rescue therapy. ;

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

• NCT number: NCT02511067
• Study type: Interventional
• Source: University of Nebraska
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 1, 2016
• Completion date: October 5, 2016