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

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Triamcinolone Acetonide 4 mg intravitreal injection
Panretinal photocoagulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetes Mellitus/ complications, Diabetic Retinopathy, Triamcinolone, Laser coagulation, Tomography, optical coherence

Eligibility Criteria

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

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Visual acuity (ETDRS)
Optic coherence tomography
Vitreous haemorrhage

Secondary Outcome Measures

Safety and Tolerance of the treatment

Full Information

First Posted
March 2, 2007
Last Updated
March 2, 2007
Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT00443521
Brief Title
Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Official Title
Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide after laser panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Diabetes Mellitus/ complications, Diabetic Retinopathy, Triamcinolone, Laser coagulation, Tomography, optical coherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide 4 mg intravitreal injection
Intervention Type
Procedure
Intervention Name(s)
Panretinal photocoagulation
Primary Outcome Measure Information:
Title
Visual acuity (ETDRS)
Title
Optic coherence tomography
Title
Vitreous haemorrhage
Secondary Outcome Measure Information:
Title
Safety and Tolerance of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Otacílio O Maia Júnior, M.D.
Organizational Affiliation
Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine, Brazil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walter Y Takahashi, M.D.
Organizational Affiliation
Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine, Brazil
Official's Role
Study Director
Facility Information:
Facility Name
Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

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

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