Efficacy and Safety Study of Intravitreal Triamcinolone to Treat Diffuse Diabetic Macular Edema (NCT00309192) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety Study of Intravitreal Triamcinolone to Treat Diffuse Diabetic Macular Edema
Spain292 participantsStarted 2006-04
Plain-language 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.
Who can participate
Age range50 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 no…
What they're measuring
1
Visual acuity stabilization or improvement 6 months after treatment.
Timeframe: 6 months
2
Macular edema reduction or stabilization 6 months after treatment.
Timeframe: 6 months
Trial details
NCT IDNCT00309192
SponsorInstituto Universitario de OftalmobiologĂa Aplicada (Institute of Applied Ophthalmobiology) - IOBA