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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00309192
Recruitment Status : Unknown
Verified September 2006 by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA.
Recruitment status was:  Recruiting
First Posted : March 31, 2006
Last Update Posted : September 14, 2006
Information provided by:
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Macular Edema Drug: Triamcinolone Acetonide 4 mg intravitreal injection Procedure: ETDRS grid laser technique Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intravitreal Triamcinolone as Treatment of the Diffuse Diabetic Macular Edema
Study Start Date : April 2006
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Primary Outcome Measures :
  1. Visual acuity stabilization or improvement 6 months after treatment.
  2. Macular edema reduction or stabilization 6 months after treatment.

Secondary Outcome Measures :
  1. Safety of the treatment.
  2. Tolerance of the treatment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00309192

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Contact: José Carlos Pastor Jimeno, MD, PhD 34 983 424761
Contact: Francisco Blázquez Araúzo, MD 34 983 423238

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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   
Contact: Francisco Blázquez Araúzo, MD    34 983 423238   
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 (Institute of Applied Ophthalmobiology) - IOBA
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Study Director: José Carlos Pastor Jimeno, MD, PhD IOBA - Instituto de Oftalmobiología Aplicada - Universidad de Valladolid

Layout table for additonal information Identifier: NCT00309192     History of Changes
Other Study ID Numbers: 2005-001385-14
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: September 14, 2006
Last Verified: September 2006
Keywords provided by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA:
Diabetes, Macular Edema, Triamcinolone
Additional relevant MeSH terms:
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Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action