NCT00309192

Brief Summary

The purpose of this study is to determine whether intravitreal injection of Triamcinolone Acetonide is effective in the treatment of Clinically Significant Diffuse Macular Edema due to Type 2 Diabetes Mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
292

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus

Timeline
Completed

Started Apr 2006

Typical duration for phase_3 diabetes-mellitus

Geographic Reach
1 country

7 active sites

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

First Submitted

Initial submission to the registry

March 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

March 14, 2023

Status Verified

January 1, 2009

Enrollment Period

3.3 years

First QC Date

March 30, 2006

Last Update Submit

March 10, 2023

Conditions

Diabetes MellitusMacular Edema

Keywords

Diabetes, Macular Edema, Triamcinolone

Outcome Measures

Primary Outcomes (2)

  • Visual acuity stabilization or improvement 6 months after treatment.

    6 months

  • Macular edema reduction or stabilization 6 months after treatment.

    6 months

Secondary Outcomes (2)

  • Safety of the treatment.

    6 months

  • Tolerance of the treatment.

    6 months

Study Arms (2)

1

EXPERIMENTAL

Triamcinolone acetonide + Grid Laser

Drug: Triamcinolone AcetonideProcedure: Grid laser

2

SHAM COMPARATOR

Sham procedure + Grid laser

Procedure: Grid laserProcedure: Sham Injection

Interventions

Triamcinolone AcetonideDRUG

Intravitreal Injection 4mg single dose

Also known as: Trigon Depot
1
Grid laserPROCEDURE

Grid laser as specified in ETDRS

12
Sham InjectionPROCEDURE

Simulation procedure for triamcinolone injection

2

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type II Diabetes.
  • Mild-moderate diabetes retinopathy.
  • Diffuse clinically significant macular edema (demonstrated by angiofluoresceingraphy, associated or not to cystic changes).
  • Age between 50 to 75 years.
  • Foveal thickening greater than 300 microns tested with Optical Coherence Tomography (OCT).
  • Visual acuity better than 0,05.

You may not qualify if:

  • Informed consent signed.
  • Data protection consent signed.
  • Bad metabolic control in recruitment stage (as criteria from Endocrinology Department of each Center) or Glicosilated Hemoglobine greater than 9%.
  • Uncontrolled hypertension. Greater than 150/90.
  • Systemic treatment with oral corticosteroids, diuretics or immunosupressors 3 months before or during the study.
  • Record of ocular hypertension induced by corticosteroids.
  • Glaucoma or ocular hypertension.
  • Unbalanced heart failure.
  • Any other pathology that could cause macular edema.
  • Associated ischemic maculopathy. (Parafoveal avascular area thickening greater than 1000 microns)
  • Patients with Clinically Significant Macular Edema with posterior hyaloid thickening or macular traction in biomicroscopy or OCT.
  • Patients with panretinophotocoagulation.
  • Patients that will probably need a panretinophotocoagulation during the study (6 to 12 months).
  • Record of ocular herpes infection.
  • Lens opacification that may interfere with clinical, photographical or OCT examinations.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

INGO - Instituto Galego de Oftalmoloxia

Santiago de Compostela, La Coruña, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Location

Instituto Oftalmológico de Alicante

Alicante, Spain

Location

Hospital de la Vall D´Hebrón

Barcelona, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, Spain

Location

Hospital General Universitario Reina Sofía

Murcia, Spain

Location

IOBA - Instituto Universitario de Oftalmobiología Aplicada

Valladolid, 47011, Spain

Location

MeSH Terms

Conditions

Diabetes MellitusMacular Edema

Interventions

Triamcinolone Acetonidesalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • José Carlos Pastor Jimeno, MD, PhD

    IOBA - Instituto de Oftalmobiología Aplicada - Universidad de Valladolid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2006

First Posted

March 31, 2006

Study Start

April 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

March 14, 2023

Record last verified: 2009-01

Locations

ES(7)