Overview

Bevacizumabe or Triamcinolone for Persistent Diabetic Macular Edema

Status:
Completed
Trial end date:
2017-12-21
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Sao Paulo
Treatments:
Bevacizumab
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Criteria
Inclusion Criteria:

- Diabetic macular edema with >300µm on central subfield macular thickness by OCT;

- Best corrected vision acuity minimum: 20/32 to 20/320;

Exclusion Criteria:

- Vitreomacular traction;

- Macular ischemia;

- Laser or injection therapy before 3 months to assign the protocol.\

- Pregnancy;