Ranibizumab for Edema of the mAcula in Diabetes: Protocol 4 With Tocilizumab: The READ-4 Study (NCT02511067) | Clinical Trial Compass
WithdrawnPhase 2
Ranibizumab for Edema of the mAcula in Diabetes: Protocol 4 With Tocilizumab: The READ-4 Study
Stopped: Funding lost and study never started
0Started 2016-10-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* • Signed informed consent and authorization of use and disclosure of protected health information
* Age ≥18 years
* Diagnosis of diabetes mellitus (type 1 or type 2)
* Serum HbA1c ≥ 5.5% and ≤10% within 12 months of randomization. (It is important to be certain that the patients in the READ-4 Study have diabetes, which will suggest that the macular edema is secondary to diabetes. The American Diabetes Association has suggested that a HbA1c ≥ 5.5% may suggest the presence of diabetes mellitus.)
* Have diabetic macular edema (DME) with central subfield thickness of ≥ 310 microns on spectral domain optical coherence tomography (SD-OCT).
* Retinal thickening secondary to diabetes mellitus involving the center of the fovea (centered-involved macular edema).
* Best corrected visual acuity score in the study eye of 20/32 to 20/400 inclusive (Snellen equivalents using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at a distance of 4 meters). If both eyes are eligible, the investigator will select the eye to be enrolled as the study eye. There is no specific visual acuity requirement for the fellow eye at time of study eye enrollment. However, if the fellow eye is to receive ranibizumab, it must have an entry visual acuity of 20/32 to 20/400 inclusive (Snellen equivalents using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at a distance of 4 meters) at the time of the initial treatment.
* In the opinion of the in…