Abstract
Purpose: :
To evaluate the effects of intravitreal injections of triamcinolone (IVTA) , bevacizumab (IVB) on refractory diffuse diabetic macular edema. In addition, the combination of both agents (IVB and trans-Tenon's retrobulbar TA injection) was also investigated.
Methods: :
The protocol of this research has been approved by Ethical Committee of Yamagata University Faculty of Medicine on the basis that this is conducted in compliance with the Declaration of Helsinki.This research has been registered as a clinical trial in UMIN Clinical Trials Registry (ID: UMIN000000921). We reviewed the medical records of the patients with diabetic macular edema, who were treated with IVTA (4mg of TA: 39 eyes of 30 cases), IVB (1.25mg: 5 eyes of 4 cases), or combination therapy (6 eyes of 4 cases). A combination therapy was done with 1.25 mg IVB and 20mg trans-Tenon’s retrobulbar TA injection. We assigned the patients to 2 groups without vitrectomy and after vitrectomy, and compared the effects. The outcome was evaluated with changes of central macular thickness (CMT) determined by optical coherence tomography.
Results: :
In the eyes without vitrectomy, CMT decreased by 41% in comparison with the baseline in the IVTA group(32 eyes), 11% in the IVB group(1 eye), and 46% in the combination group. A mean duration of improvement in CMT was 5 months in the IVTA group. In the eyes after vitrectomy, CMT decreased by 39% in the IVTA group (7 eyes), 46% in the IVB group(4 eyes), and 68% in the combination group(4 eyes). A duration of improvement in CMT was 0.25 months in the IVTA group, 0.25 month in the IVB group, 2 months in the combination group.
Conclusions: :
In the eyes without vitrectomy, IVTA was effective, and in the those after vitrectomy, the combination of bevacizumab and triamcinolone improved the outcomes in comparison with the monotherapy.
Clinical Trial: :
www.umin.ac.jp/ctr/index/htm UMIN000000921
Keywords: diabetic retinopathy • edema • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials