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

Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Macular Edema

Intervention: Bevacizumab intravitreal (Drug); Triamcinolone (Drug); Triamcinolone + Bevacizumab (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Federal University of São Paulo

Official(s) and/or principal investigator(s):
Rubens Belfort Jr, MD, Principal Investigator, Affiliation: Federal University of São Paulo / Dept. of OPhthalmology

Overall contact:
Rubens Belfort Jr, MD, Phone: 5511-55726443, Email: clinbelf@uol.com.br

Summary

Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

Clinical Details

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

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

Primary outcome: Measurement of visual acuity (E Snellen)

Secondary outcome:

Tonometry

Measurement of retinal thickness by OCT

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Rubens Belfort Jr, MD, Phone: 5511-55726443, Email: clinbelf@uol.com.br

Federal University of Sao Paulo - Dept. of Ophthalmology / Vision Institute, São Paulo 04040-002, Brazil; Recruiting
Cristina Muccioli, MD, Phone: 5511-50845878, Email: cmucciol@uol.com.br
Luci MP Silva, MBA, Phone: 5511-55726443, Email: luci@oftalmo.epm.br
Hermelino LO Neto, MD, Sub-Investigator
Rafael E Andrade, MD, Sub-Investigator
Michel E Farah, MD, Sub-Investigator
Andre C Branco, MD, Sub-Investigator
Mauricio Maia, MD, Sub-Investigator
José A Cardillo, MD, Sub-Investigator
Marcelo Casella, MD, Sub-Investigator
Mario Nóbrega, MD, Sub-Investigator
Cristina Muccioli, MD, Sub-Investigator
Magno Ferreira, MD, Sub-Investigator
Additional Information

Starting date: August 2008
Last updated: June 21, 2011

Page last updated: August 23, 2015

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