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

• Status: Unknown status
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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.