NCT00443521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
Last Updated

March 6, 2007

Status Verified

March 1, 2007

First QC Date

March 2, 2007

Last Update Submit

March 2, 2007

Conditions

Diabetic Retinopathy

Keywords

Diabetes Mellitus/ complicationsDiabetic RetinopathyTriamcinoloneLaser coagulationTomography, optical coherence

Outcome Measures

Primary Outcomes (3)

  • Visual acuity (ETDRS)

  • Optic coherence tomography

  • Vitreous haemorrhage

Secondary Outcomes (1)

  • Safety and Tolerance of the treatment

Interventions

Triamcinolone Acetonide 4 mg intravitreal injectionDRUG
Panretinal photocoagulationPROCEDURE

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Diabetic RetinopathyDiabetes Complications

Interventions

Triamcinolone AcetonideIntravitreal Injections

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedInjections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Otacílio O Maia Júnior, M.D.

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

    PRINCIPAL INVESTIGATOR

  • Walter Y Takahashi, M.D.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 6, 2007

Study Start

March 1, 2005

Study Completion

July 1, 2006

Last Updated

March 6, 2007

Record last verified: 2007-03

Locations

BR(1)