Status:
COMPLETED
Efficacy and Safety Study of Intravitreal Triamcinolone to Treat Diffuse Diabetic Macular Edema
Lead Sponsor:
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborating Sponsors:
Fondo de Investigacion Sanitaria
Conditions:
Diabetes Mellitus
Macular Edema
Eligibility:
All Genders
50-75 years
Phase:
PHASE3
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...
Detailed Description
Diabetes mellitus and its complications represent nowadays an important issue in Public Health terms. The WHO expectations indicate that around 2025 the European population with diabetes will reach ab...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT00309192
Start Date
April 1 2006
End Date
July 1 2009
Last Update
March 14 2023
Active Locations (7)
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1
INGO - Instituto Galego de Oftalmoloxia
Santiago de Compostela, La Coruña, Spain
2
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
3
Instituto Oftalmológico de Alicante
Alicante, Spain
4
Hospital de la Vall D´Hebrón
Barcelona, Spain