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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Instituto Universitario de Oftalmobiología Aplicada.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier:
NCT00309192
First received: March 30, 2006
Last updated: September 13, 2006
Last verified: September 2006
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intravitreal Triamcinolone as Treatment of the Diffuse Diabetic Macular Edema

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Edema
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
INGO - Instituto Galego de Oftalmoloxia Not yet recruiting
Santiago de Compostela, La Coruña, Spain
Principal Investigator: Francisco Gómez Ulla de Irazabal, MD, PhD            
Clínica Universitaria de Navarra Not yet recruiting
Pamplona, Navarra, Spain
Principal Investigator: Alfredo García Layana, MD, PhD            
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            
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

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

Keywords provided by Instituto Universitario de Oftalmobiología Aplicada:
Diabetes, Macular Edema, Triamcinolone

Additional relevant MeSH terms:
Edema
Macular Edema
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
 Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013