Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema - Full Text View

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 Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide Bevacizumab

U.S. FDA Resources

Further study details as provided by Rubens Belfort Jr., Federal University of São Paulo:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


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)
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

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
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 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

ClinicalTrials.gov processed this record on June 22, 2017

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