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 range
50 Years – 75 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA