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

Diabetic Macular Edema Clinical Trial

— ATEMD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737971
• Other study ID #: 108/08
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2008
• Last updated: April 29, 2016
• Start date: August 2008
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Bevacizumab intravitreal
Bevacizumab intravitreal 0.05 ml/1.25 mg - administered on D0, Week 4, Week 8
• Triamcinolone
Intravitreal 0.1 ml/4 mg, D0, Week 4 and Week 8
• Triamcinolone + Bevacizumab
Intravitreal triamcinolone 0.1 ml/4 mg + bevacizumab 0.05 ml/1.25 mg simultaneously on D0, week 4, Week 8

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo - Dept. of Ophthalmology / Vision Institute	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Rubens Belfort Jr.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of visual acuity (E Snellen)		monthly	Yes
Secondary	Tonometry		monthly	Yes
Secondary	Measurement of retinal thickness by OCT		monthly	Yes