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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by University of Sao Paulo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00801450
First Posted: December 3, 2008
Last Update Posted: October 12, 2009
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.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
  Purpose
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 Intervention Phase
Diabetic Macular Edema Drug: Triamcinolone acetonide Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

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

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

Enrollment: 24
Study Start Date: September 2007
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravitreal (IVI) Drug: Triamcinolone acetonide
4 mg
Experimental: SubTenon´s (STI) Drug: Triamcinolone acetonide
40 mg

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00801450


Locations
Brazil
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
  More Information

Publications:
Responsible Party: Rodrigo Jorge, University of São Paulo
ClinicalTrials.gov Identifier: NCT00801450     History of Changes
Other Study ID Numbers: 2995/2007
First Submitted: December 2, 2008
First Posted: December 3, 2008
Last Update Posted: October 12, 2009
Last Verified: October 2009

Keywords provided by University of Sao Paulo:
diabetes
macular edema
triamcinolone
cataract
refractory diabetic macular edema

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action