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

Primary Purpose

Diabetic Macular Edema

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Triamcinolone acetonide
Triamcinolone acetonide
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring diabetes, macular edema, triamcinolone, cataract, refractory diabetic macular edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intravitreal (IVI)

SubTenon´s (STI)

Arm Description

Outcomes

Primary Outcome Measures

central subfield macular thickness

Secondary Outcome Measures

Best Corrected Visual Acuity
Intraocular pressure

Full Information

First Posted
December 2, 2008
Last Updated
October 8, 2009
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00801450
Brief Title
Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
diabetes, macular edema, triamcinolone, cataract, refractory diabetic macular edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal (IVI)
Arm Type
Experimental
Arm Title
SubTenon´s (STI)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide
Intervention Description
4 mg
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide
Intervention Description
40 mg
Primary Outcome Measure Information:
Title
central subfield macular thickness
Time Frame
baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively
Secondary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Time Frame
baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively
Title
Intraocular pressure
Time Frame
baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19027427
Citation
Kumar V, Ghosh B, Raina UK, Goel N. Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on persistent diffuse diabetic macular edema. Am J Ophthalmol. 2008 Dec;146(6):974; author reply 974-5. doi: 10.1016/j.ajo.2008.08.013. No abstract available.
Results Reference
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PubMed Identifier
16978576
Citation
Audren F, Lecleire-Collet A, Erginay A, Haouchine B, Benosman R, Bergmann JF, Gaudric A, Massin P. Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg. Am J Ophthalmol. 2006 Nov;142(5):794-99. doi: 10.1016/j.ajo.2006.06.011. Epub 2006 Sep 15.
Results Reference
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PubMed Identifier
16186372
Citation
Bonini-Filho MA, Jorge R, Barbosa JC, Calucci D, Cardillo JA, Costa RA. Intravitreal injection versus sub-Tenon's infusion of triamcinolone acetonide for refractory diabetic macular edema: a randomized clinical trial. Invest Ophthalmol Vis Sci. 2005 Oct;46(10):3845-9. doi: 10.1167/iovs.05-0297.
Results Reference
background
PubMed Identifier
17965109
Citation
Paccola L, Costa RA, Folgosa MS, Barbosa JC, Scott IU, Jorge R. Intravitreal triamcinolone versus bevacizumab for treatment of refractory diabetic macular oedema (IBEME study). Br J Ophthalmol. 2008 Jan;92(1):76-80. doi: 10.1136/bjo.2007.129122. Epub 2007 Oct 26.
Results Reference
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Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery

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