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

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

Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Bevacizumab intravitreal; Drug: Triamcinolone; Drug: Triamcinolone + Bevacizumab

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04040-002
    • Federal University of Sao Paulo - Dept. of Ophthalmology / Vision Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: triamcinolone + avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of visual acuity (E Snellen)	monthly

Secondary Outcome Measures

Outcome Measure	Time Frame
Tonometry	monthly
Measurement of retinal thickness by OCT	monthly

Collaborators and Investigators

• Sponsor: Rubens Belfort Jr.
• Investigators: Principal Investigator: Rubens Belfort Jr, MD, Federal University of São Paulo / Dept. of OPhthalmology

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 19, 2008
• First Submitted That Met QC Criteria: August 19, 2008
• First Posted (Estimate): August 20, 2008

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: April 29, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: bevacizumab; avastin; triamcinolone; diabetic macular edema; macular edema; intravitreal injection
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 108/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No