Bevacizumabe or Triamcinolone for Persistent Diabetic Macular Edema
Status:
Completed
Trial end date:
2017-12-21
Target enrollment:
Participant gender:
Summary
Background: Diabetic macular edema (DME) shows a sustained functional and morphologic
response to anti-vascular endothelial growth factor (VEGF) drugs, but the optimal approach
for persistent macular edema still in debate.
Purpose: To evaluate 24-week visual and anatomical effects of intravitreal bevacizumabe or
triamcinolone in patients who had residual edema after 24-weeks to "pro re nata"(prn)
intravitreal bevacizumabe therapy.
Methods: This study enrolled a total of 100 DME eyes. Each patient received "prn"
bevacizumabe therapy throughout 24 weeks. At week 24, patients who had recurrent or
persistent edema were randomized 1:1 to Group 1 (prn bevacizumane) or Group 2 (prn
triamcinolone). Patients with no recurrent or persistent edema at week 24 were comprised
Group 3 and continue received prn bevacizumabe. Prn treatment was administered when central
subfield thickness of the macula (CST) > 300 µm and/or there were intraretinal cystoid spaces
in the fovea. Study visits occurred every 4 weeks with the endpoint at week 48. At each
visit, patients had an eye exam and CST, best-corrected visual acuity (BCVA), and intraocular
pressure (IOP) were assessed. Fundus photography and fluorescein angiography were also
performed at baseline, week 16, week 40, and week 48. Rescue therapy using laser
photocoagulation could be administered at the discretion of the Investigators. All patients
resumed standard care after exiting.