Bevacizumabe or Triamcinolone for Persistent Diabetic Macular Edema (BEVATAAC)
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|ClinicalTrials.gov Identifier: NCT02985619|
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : October 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Drug: Bevacizumab Drug: Triamcinolone Acetonide||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial Evaluating Bevacizumabe or Triamcinolone for Persistent Diabetic Macular Edema|
|Actual Study Start Date :||July 21, 2016|
|Actual Primary Completion Date :||April 14, 2017|
|Actual Study Completion Date :||December 21, 2017|
Active Comparator: Bevacizumabe
6 months treatment with 0.05ml (1.25mg) intravitreous injection of Bevacizumabe "prn" (pro re nata), monthly for central sufoveal thickness map more than 300µm by Optic Coherence Tomography.
Other Name: Avastin
Active Comparator: Triamcinolone
6 months treatment with 0.03ml (1mg) intravitreous injection of triamcinolone each 3 months for central sufoveal thickness map more than 300µm by Optic Coherence Tomography.
Drug: Triamcinolone Acetonide
- Optical Coherence Tomography measurements in the central subfield thickness between baseline and 6 months 1st endpoint. [ Time Frame: 6 months. ]