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

NCT ID: NCT00737971

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2013-12-31

Brief Summary

Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

Detailed Description

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

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Avastin intravitreal injection D0, Week 4, Week 8

Group Type: ACTIVE_COMPARATOR

Bevacizumab intravitreal

Intervention Type: DRUG

Bevacizumab intravitreal 0.05 ml/1.25 mg - administered on D0, Week 4, Week 8

B

Triamcinolone intravitreal injection

Group Type: ACTIVE_COMPARATOR

Triamcinolone

Intervention Type: DRUG

Intravitreal 0.1 ml/4 mg, D0, Week 4 and Week 8

C

Avastin + Triamcinolone intravitreal injection simultaneously

Group Type: ACTIVE_COMPARATOR

Triamcinolone + Bevacizumab

Intervention Type: DRUG

Intravitreal triamcinolone 0.1 ml/4 mg + bevacizumab 0.05 ml/1.25 mg simultaneously on D0, week 4, Week 8

Interventions

Bevacizumab intravitreal

Bevacizumab intravitreal 0.05 ml/1.25 mg - administered on D0, Week 4, Week 8

Intervention Type: DRUG

Triamcinolone

Intravitreal 0.1 ml/4 mg, D0, Week 4 and Week 8

Intervention Type: DRUG

Triamcinolone + Bevacizumab

Intravitreal triamcinolone 0.1 ml/4 mg + bevacizumab 0.05 ml/1.25 mg simultaneously on D0, week 4, Week 8

Intervention Type: DRUG

Other Intervention Names

Avastin; triamcinolone + avastin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rubens Belfort Jr.

OTHER

Sponsor Role: lead

Responsible Party

Rubens Belfort Jr.

Head Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rubens Belfort Jr, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo / Dept. of OPhthalmology

Locations

Federal University of Sao Paulo - Dept. of Ophthalmology / Vision Institute

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

108/08

Identifier Type: -

Identifier Source: org_study_id