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
Information provided by:
Instituto Universitario de Oftalmobiología Aplicada
First received: March 30, 2006
Last updated: September 13, 2006
Last verified: September 2006
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.
Drug: Triamcinolone Acetonide 4 mg intravitreal injection
Procedure: ETDRS grid laser technique
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
||Efficacy and Safety of Intravitreal Triamcinolone as Treatment of the Diffuse Diabetic Macular Edema
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:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||50 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00309192
|INGO - Instituto Galego de Oftalmoloxia
|Santiago de Compostela, La Coruña, Spain |
|Principal Investigator: Francisco Gómez Ulla de Irazabal, MD, PhD |
|Clínica Universitaria de Navarra
|Pamplona, Navarra, Spain |
|Principal Investigator: Alfredo García Layana, MD, PhD |
|Instituto Oftalmológico de Alicante
|Alicante, Spain |
|Principal Investigator: José María Ruiz Moreno, MD, PhD |
|Hospital de la Vall D´Hebrón
|Barcelona, Spain |
|Principal Investigator: José García Arumí, MD, PhD |
|Hospital Clínico Universitario San Carlos
|Madrid, Spain |
|Principal Investigator: Juan Donate López, MD, PhD |
|Hospital General Universitario Reina Sofía
|Murcia, Spain |
|Principal Investigator: Inmaculada Selles, MD, PhD |
|IOBA - Instituto Universitario de Oftalmobiología Aplicada
|Valladolid, Spain, 47005 |
|Contact: José Carlos Pastor Jimeno, MD, PhD 34 9834761 email@example.com |
|Contact: Francisco Blázquez Araúzo, MD 34 983 423238 firstname.lastname@example.org |
|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 |
Instituto Universitario de Oftalmobiología Aplicada
||José Carlos Pastor Jimeno, MD, PhD
||IOBA - Instituto de Oftalmobiología Aplicada - Universidad de Valladolid
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 30, 2006
||September 13, 2006
||Spain: Spanish Agency of Medicines
Keywords provided by Instituto Universitario de Oftalmobiología Aplicada:
Diabetes, Macular Edema, Triamcinolone
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 02, 2014
Glucose Metabolism Disorders
Endocrine System Diseases
Signs and Symptoms
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action