Efficacy and Safety Study of Intravitreal Triamcinolone to Treat Diffuse Diabetic Macular Edema

This study is currently recruiting participants.

Verified by Instituto Universitario de Oftalmobiología Aplicada, September 2006

First Received: March 30, 2006 Last Updated: September 13, 2006 History of Changes

Sponsor:	Instituto Universitario de Oftalmobiología Aplicada
Information provided by:	Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier:	NCT00309192

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus Macular Edema	Drug: Triamcinolone Acetonide 4 mg intravitreal injection Procedure: ETDRS grid laser technique	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy and Safety of Intravitreal Triamcinolone as Treatment of the Diffuse Diabetic Macular Edema

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Diabetes Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Instituto Universitario de Oftalmobiología Aplicada:

Primary Outcome Measures:

Visual acuity stabilization or improvement 6 months after treatment.
Macular edema reduction or stabilization 6 months after treatment.

Secondary Outcome Measures:

Safety of the treatment.
Tolerance of the treatment.

Estimated Enrollment:	292
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2008

Show Detailed Description

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
None of the exclusion criteria.
Informed consent signed.
Data protection consent signed.

Exclusion Criteria:

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.
Toxoplasmosis, active or not in the study eye.
Vitrectomy in either eye.
Record of Central Serose Coroidopathy.
Pseudophakic patients with less than 6 months since surgery.
Patients with any other situation that may interfere in study completion based in Investigator´s opinion.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309192

Contacts

Contact: José Carlos Pastor Jimeno, MD, PhD	34 983 424761	pastor@ioba.med.uva.es
Contact: Francisco Blázquez Araúzo, MD	34 983 423238	blazquez@ioba.med.uva.es

Locations

Spain
Instituto Oftalmológico de Alicante	Not yet recruiting
Alicante, Spain
Principal Investigator: José María Ruiz Moreno, MD, PhD
Hospital de la Vall D´Hebrón	Not yet recruiting
Barcelona, Spain
Principal Investigator: José García Arumí, MD, PhD
Hospital Clínico Universitario San Carlos	Not yet recruiting
Madrid, Spain
Principal Investigator: Juan Donate López, MD, PhD
Hospital General Universitario Reina Sofía	Not yet recruiting
Murcia, Spain
Principal Investigator: Inmaculada Selles, MD, PhD
IOBA - Instituto Universitario de Oftalmobiología Aplicada	Recruiting
Valladolid, Spain, 47005
Contact: José Carlos Pastor Jimeno, MD, PhD 34 9834761 pastor@ioba.med.uva.es
Contact: Francisco Blázquez Araúzo, MD 34 983 423238 blazquez@ioba.med.uva.es
Principal Investigator: José Carlos Pastor Jimeno, MD, PhD
Sub-Investigator: María Isabel López Gálvez, MD, PhD
Sub-Investigator: Miguel Ángel De la Fuente, MD
Sub-Investigator: Enrique Rodríguez de la Rua, MD, PhD
Spain, La Coruña
INGO - Instituto Galego de Oftalmoloxia	Not yet recruiting
Santiago de Compostela, La Coruña, Spain
Principal Investigator: Francisco Gómez Ulla de Irazabal, MD, PhD
Spain, Navarra
Clínica Universitaria de Navarra	Not yet recruiting
Pamplona, Navarra, Spain
Principal Investigator: Alfredo García Layana, MD, PhD

Sponsors and Collaborators

Instituto Universitario de Oftalmobiología Aplicada

Investigators

Study Director:

José Carlos Pastor Jimeno, MD, PhD

IOBA - Instituto de Oftalmobiología Aplicada - Universidad de Valladolid

More Information

No publications provided

Study ID Numbers:	2005-001385-14, PI071701
Study First Received:	March 30, 2006
Last Updated:	September 13, 2006
ClinicalTrials.gov Identifier:	NCT00309192 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Instituto Universitario de Oftalmobiología Aplicada:

Diabetes, Macular Edema, Triamcinolone

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Hormones
Triamcinolone hexacetonide
Signs and Symptoms
Macular Edema
Triamcinolone Acetonide
Therapeutic Uses
Triamcinolone

Retinal Diseases
Metabolic Diseases
Eye Diseases
Diabetes Mellitus
Retinal Degeneration
Macular Degeneration
Endocrine System Diseases
Triamcinolone diacetate
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010