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 because the information has not been verified recently.
Verified October 2009 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00801450
First received: December 2, 2008
Last updated: October 8, 2009
Last verified: October 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 2, 2008
Last Updated: October 8, 2009
Health Authority: Brazil: National Committee of Ethics in Research

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
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014