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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
Sponsor:
Information provided by (Responsible Party):
Murilo Wendeborn Rodrigues Junior, University of Sao Paulo

Brief 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.


Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Bevacizumab Drug: Triamcinolone Acetonide Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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.
Drug: Bevacizumab
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



Primary Outcome Measures :
  1. Optical Coherence Tomography measurements in the central subfield thickness between baseline and 6 months 1st endpoint. [ Time Frame: 6 months. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
  Study Documents (Full-Text)

Documents provided by Murilo Wendeborn Rodrigues Junior, University of Sao Paulo:

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Responsible Party: Murilo Wendeborn Rodrigues Junior, USP Ribeirao Preto, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02985619     History of Changes
Other Study ID Numbers: 1.599.864
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action