Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
Study NCT ID:
NCT02511067
Status:
WITHDRAWN
Last Update Posted:
2023-08-15
First Post:
2015-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ranibizumab for Edema of the mAcula in Diabetes: Protocol 4 With Tocilizumab: The READ-4 Study
Sponsor:
University of Nebraska
Organization:
Study Overview
Official Title:
Evaluation Of the Safety, Tolerability and Efficacy of Ranibizumab and Tocilizumab in Eyes With Diabetic Macular Edema.
Status:
WITHDRAWN
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding lost and study never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
READ-4
Brief 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.
Detailed 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: