Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

March 2, 2007 updated by: University of Sao Paulo
The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide after laser panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. Therefore this study is designed using both treatments in the same patient: intravitreal triamcinolone plus panretinal photocoagulation in one eye, compared to panretinal photocoagulation alone in the contralateral eye. These patients had their visual acuity measured and complete ophthalmological examination was performed, including macular slit lamp examination, fluorescein angiography and optical coherence tomography.

Patients with symmetric proliferative diabetic retinopathy without high risk characteristics receive laser therapy in both eyes and triamcinolone injections in one eye. For the triamcinolone injections, numbing drops, antibiotic drops, and drops to dilate the pupil, and possibly and anesthetic injection, are put in the eye before the medicine is injected into the vitreous. Patients return for follow-up visits 1 day, 1 and 4 weeks after the injection, and then 3 and 6 months. Patients whose condition does not improve may undergo new evaluation.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2
  • Phase 3

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, Brazil, 05403-000
        • Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine

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

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type II Diabetes
  • symmetric proliferative diabetic retinopathy without high risk characteristics
  • Informed consent signed

Exclusion Criteria:

  • previous treatment for diabetic retinopathy
  • media opacities that may interfere with clinical, photographically or OCT examinations
  • inability to understands the implications of the protocol
  • Glaucoma or ocular hypertension
  • Any other pathology that could cause retinal alterations
  • Patients with any other situation that may interfere in study completion based in Investigator´s opinion

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Visual acuity (ETDRS)
Optic coherence tomography
Vitreous haemorrhage

Secondary Outcome Measures

Outcome Measure
Safety and Tolerance of the treatment

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

  • Principal Investigator: Otacílio O Maia Júnior, M.D., Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine, Brazil
  • Study Director: Walter Y Takahashi, M.D., Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine, Brazil

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

March 1, 2005

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 2, 2007

First Posted (ESTIMATE)

March 6, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2007

Last Update Submitted That Met QC Criteria

March 2, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 310/05

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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