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Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema (ATEMD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rubens Belfort Jr., Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00737971
First received: August 19, 2008
Last updated: April 29, 2016
Last verified: April 2016
  Purpose
Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

Condition Intervention Phase
Diabetic Macular Edema
Drug: Bevacizumab intravitreal
Drug: Triamcinolone
Drug: Triamcinolone + Bevacizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel Group, Masked Clinical Study to Evaluate the Efficacy of Triamcinolone and Bevacizumab Through Intravitreal Injection With Individual or Simultaneous Drugs to Treatment of Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Measurement of visual acuity (E Snellen) [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tonometry [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
  • Measurement of retinal thickness by OCT [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

Enrollment: 142
Study Start Date: August 2008
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Avastin intravitreal injection D0, Week 4, Week 8
Drug: Bevacizumab intravitreal
Bevacizumab intravitreal 0.05 ml/1.25 mg - administered on D0, Week 4, Week 8
Other Name: Avastin
Active Comparator: B
Triamcinolone intravitreal injection
Drug: Triamcinolone
Intravitreal 0.1 ml/4 mg, D0, Week 4 and Week 8
Active Comparator: C
Avastin + Triamcinolone intravitreal injection simultaneously
Drug: Triamcinolone + Bevacizumab
Intravitreal triamcinolone 0.1 ml/4 mg + bevacizumab 0.05 ml/1.25 mg simultaneously on D0, week 4, Week 8
Other Name: triamcinolone + avastin

Detailed Description:
Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age at least
  • Diagnosis of diabetes mellitus (type 1 or type 2. any one of the following will be considered to be sufficient evidence that diabetes is present:

    • current regular use of insulin for the treatment of diabetes
    • current regular use of oral hypoglycemic agents for the treatment of diabetes
    • diabetes as defined by american Diabetes Association (ADA)
    • symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) or eighth-hour fasting plasma glucose > 126 mg/dl
  • Diabetic macular edema clinically observable associated with diabetic retinopathy:

    • without prior foveal treatment with laser therapy
    • if photocoagulation or peripherical or macular laser, at least 3 months
    • absence of macular ischemia by fluorescein angiography on baseline visit
  • BCVA score between 20 letters (20/400 ETDRS)e 70 letters (20/40 ETDRS) in the study eye measured by the ETDRS method at qualification/baseline visit
  • Retinal thickness > 275um by OCT
  • One eye per patient will be chosen for the study. In case of both eye eligible, it will be chosen an eye to be treated with study medication and another eye treated with laser
  • Taught hyaloid syndrome

Exclusion Criteria:

  • Uncontrolled systemic disease
  • Initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification visit
  • Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification visit
  • Any ocular condition in the study eye that in the opinion of the investigator would prevent a 2 lines improvement of visual acuity (e.g. severe macular ischemia)
  • Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid edema or any other condition in the study eye which could be contributing to macular edema
  • Presence of an epiretinal membrane in the study eye
  • History of IOP elevation in response to steroid treatment in either eye
  • History of glaucoma or optic nerve head change consistent with glaucoma damage
  • Ocular hypertension requiring more than 1 anti-glaucoma medication to maintain IOP < 11mmhg at qualification visit
  • Presence of anterior chamber intraocular lens in the study eye
  • Active optic disc or retinal neovascularization in the study eye at qualification visit
  • Active or history of choroidal neovascularization in the study eye
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737971

Locations
Brazil
Federal University of Sao Paulo - Dept. of Ophthalmology / Vision Institute
São Paulo, Brazil, 04040-002
Sponsors and Collaborators
Rubens Belfort Jr.
Investigators
Principal Investigator: Rubens Belfort Jr, MD Federal University of São Paulo / Dept. of OPhthalmology
  More Information

Responsible Party: Rubens Belfort Jr., Head Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00737971     History of Changes
Other Study ID Numbers: 108/08 
Study First Received: August 19, 2008
Last Updated: April 29, 2016
Health Authority: Brazil: National Committee of Ethics in Research
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: data presented in several congresses: ARVO 2010-- poster ARVO 2011, WOC BERLIN 2010, WOC ABU DABHI 2012 (partial data) CBO 2014 (final data)

Keywords provided by Federal University of São Paulo:
avastin
bevacizumab
triamcinolone
diabetic macular edema
macular edema
intravitreal injection

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016