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

Study Description

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Brief Summary:

Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

Condition or disease	Intervention/treatment	Phase
Diabetic Macular Edema	Drug: Bevacizumab intravitreal; Drug: Triamcinolone; Drug: Triamcinolone + Bevacizumab	Phase 4

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	142 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	August 2008
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2013

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Measurement of visual acuity (E Snellen) [ Time Frame: monthly ]

Secondary Outcome Measures :

1. Tonometry [ Time Frame: monthly ]
2. Measurement of retinal thickness by OCT [ Time Frame: monthly ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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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
First Posted:	August 20, 2008
Last Update Posted:	May 3, 2016
Last Verified:	April 2016
Individual Participant Data (IPD) Sharing Statement:
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 Rubens Belfort Jr., 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