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Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00801450
Recruitment Status : Unknown
Verified October 2009 by University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : December 3, 2008
Last Update Posted : October 12, 2009
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo

Brief Summary:
Triamcinolone has already been used by different routes of administration to treat diabetic macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in eyes with refractory diffuse diabetic macular edema are tested.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Triamcinolone acetonide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2007
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Edema

Arm Intervention/treatment
Experimental: Intravitreal (IVI) Drug: Triamcinolone acetonide
4 mg

Experimental: SubTenon´s (STI) Drug: Triamcinolone acetonide
40 mg

Primary Outcome Measures :
  1. central subfield macular thickness [ Time Frame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively ]

Secondary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively ]
  2. Intraocular pressure [ Time Frame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Refractory diffuse DME unresponsive to focal laser photocoagulation
  • Best corrected visual acuity between 20/800 and 20/40; Central subfield macular thickness greater than 300 µm

Exclusion Criteria:

  • Previous ocular surgery
  • Glycosylated hemoglobin (Hb A1C) rate above 10%
  • History of glaucoma or ocular hypertension
  • Loss of vision as a result of other causes
  • Systemic corticoid therapy
  • Severe systemic disease
  • Any condition affecting follow-up or documentation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00801450

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Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
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Responsible Party: Rodrigo Jorge, University of São Paulo Identifier: NCT00801450    
Other Study ID Numbers: 2995/2007
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: October 12, 2009
Last Verified: October 2009
Keywords provided by University of Sao Paulo:
macular edema
refractory diabetic macular edema
Additional relevant MeSH terms:
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Macular Edema
Signs and Symptoms
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action