About the Study
Ranibizumab (RBZ) is a monoclonal antibody against vascular endothelial grown factor (VEGF). VEGF is up-regulated in eyes with diabetic retinopathy and diabetic macular edema (DME). Numerous clinical trials have demonstrated that intravitreal RBZ, when administered at 0.5 mg per intravitreal injection, has bioactivity in the management of diabetic macular edema (DME) because it decreases retinal thickness and improves best corrected visual acuity (BCVA). However, studies have shown that repeated intravitreal injections of RBZ are required to treat DME; therefore, a higher dose of RBZ may have the potential of providing more VEGF inhibition, which could be beneficial in eyes with DME.
The objective of the multi-center READ 3 Study is to investigate the bioactivity, safety, and tolerability of two different dosages (0.5 mg and 2.0 mg) of RBZ in patients with DME. Eligible patients will be enrolled from 13 clinical sites throughout the United States and will be randomized 1:1 to receive one of the two doses. Each patient will receive intravitreal injections of RBZ in the designated study eye for 6 mandatory treatments at baseline and months 1, 2, 3, 4, and 5. After the primary endpoint has been assessed at month 6, subjects will be examined monthly, and if the study eye meets retreatment criteria, it will continue to receive intravitreal injections of RBZ. Each subject will be followed monthly for a duration of 12 months.
The primary endpoint of the study, which is the safety evaluation of 2 different doses of RBZ, will be assessed at month 6. Secondary endpoints, including changes in BCVA scores and anatomic retinal changes as assessed by color fundus photography, fluorescein angiography, and OCT, will be assessed at months 3, 9, and 12.
If the fellow eye also has DME, at the discretion of the investigator at any time during the study, it can be treated with the opposite dose of RBZ to which the study eye has been randomized. Under no circumstances will both eyes be treated with the same dose of RBZ.
The results of the READ 3 Study will provide additional information on the role of VEGF inhibition for DME and may have a significant impact on the future management of the disease.