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

Phase 4

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Triamcinolone; Drug: Triamcinolone + Bevacizumab; Drug: Bevacizumab intravitreal

• Registration Number: NCT00737971
• Lead Sponsor: Rubens Belfort Jr.

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

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Triamcinolone	Triamcinolone intravitreal injection
C	Triamcinolone + Bevacizumab	Avastin + Triamcinolone intravitreal injection simultaneously
A	Bevacizumab intravitreal	Avastin intravitreal injection D0, Week 4, Week 8

Primary Outcome Measures

Name	Time	Method
Measurement of visual acuity (E Snellen)	monthly

Secondary Outcome Measures

Name	Time	Method
Tonometry	monthly
Measurement of retinal thickness by OCT	monthly

Trial Locations

Locations (1)

Federal University of Sao Paulo - Dept. of Ophthalmology / Vision Institute; 🇧🇷 São Paulo, Brazil