Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema (ATEMD)
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ClinicalTrials.gov Identifier: NCT00737971 |
Recruitment Status
:
Completed
First Posted
: August 20, 2008
Last Update Posted
: May 3, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Edema | Drug: Bevacizumab intravitreal Drug: Triamcinolone Drug: Triamcinolone + Bevacizumab | Phase 4 |
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 |

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
|
- Measurement of visual acuity (E Snellen) [ Time Frame: monthly ]
- Tonometry [ Time Frame: monthly ]
- Measurement of retinal thickness by OCT [ Time Frame: monthly ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737971
Brazil | |
Federal University of Sao Paulo - Dept. of Ophthalmology / Vision Institute | |
São Paulo, Brazil, 04040-002 |
Principal Investigator: | Rubens Belfort Jr, MD | Federal University of São Paulo / Dept. of OPhthalmology |
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 Key Record Dates |
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 |