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

October 8, 2009 updated by: University of Sao Paulo
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravitreal (IVI)
Drug: Triamcinolone acetonide
4 mg
Drug: Triamcinolone acetonide
40 mg
Experimental: SubTenon´s (STI)
Drug: Triamcinolone acetonide
4 mg
Drug: Triamcinolone acetonide
40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
central subfield macular thickness
Time Frame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively
baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Best Corrected Visual Acuity
Time Frame: baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively
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
baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (Estimate)

December 3, 2008

Study Record Updates

Last Update Posted (Estimate)

October 12, 2009

Last Update Submitted That Met QC Criteria

October 8, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2995/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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