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.