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| Sponsor: | Samsung Medical Center |
|---|---|
| Information provided by: | Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT00371410 |
Purpose
Macular edema constitutes the primary cause of visual impairment in diabetic patients with a disease duration of 20 years or more. Intravitreal triamcinolone (IVTA) and macular focal laser photocoagulation were reported to generate favorable results in the treatment of diabetic macular edema, but there have been patients with diffuse diabetic macular edema refractory to such treatment modalities. The present study will test the safety and the efficacy of the combined treatment of vitrectomy, IVTA and macular focal laser photocoagulation in the treatment of intractable diffuse diabetic macular edema.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Macular Edema |
Procedure: vitrectomy Drug: intravitreal triamcinolone acetonide Procedure: macular focal laser photocoagulation |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | The Safety and the Efficacy of Combined Vitrectomy, Intravitreal Triamcinolone Acetonide and Macular Focal Laser Photocoagulation for the Treatment of Intractable Diffuse Diabetic Macular Edema |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | October 2007 |
Fifty eyes from 50 diabetic patients were included, who had been diagnosed with intractable diffuse diabetic macular edema (DME). Intractable diffuse DME was defined as a biomicroscopically, angiographically and tomographically proven diffuse DME, which did not respond to or recurred after the previous intravitreal triamcinolone acetonide (IVTA) and/or macular focal laser photocoagulation. The central macular thickness (CMT) had to be greater than 250 μm. Preoperative ocular examination included best corrected visual acuity (BCVA) using the ETDRS chart, applanation tonometry, slit-lamp biomicroscopy, dilated fundus examination, optical coherence tomography (OCT) and fluorescein angiography. Pars plana vitrectomy with removal of retinal internal limiting membrane (ILM) was performed in all the 50 subject eyes. On the day after vitrectomy, triamcinolone acetonide (0.1 mL, 40 mg/mL) was injected intravitreally. Macular focal laser photocoagulation was performed 2 weeks after vitrectomy. As main outcome measures, BCVA was recorded and the CMT was measured using OCT by independent observers for all subjects at 3 and 6 months after the laser photocoagulation.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | 2006-05-029 |
| Study First Received: | August 31, 2006 |
| Last Updated: | August 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00371410 History of Changes |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
|
Vitrectomy Intravitreal triamcinolone acetonide Macular focal laser photocoagulation Best-corrected visual acuity Central macular thickness |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Eye Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Edema Macular Degeneration Retinal Degeneration Enzyme Inhibitors Triamcinolone diacetate |
Immunosuppressive Agents Hormones Glucocorticoids Pharmacologic Actions Triamcinolone hexacetonide Macular Edema Signs and Symptoms Triamcinolone Acetonide Therapeutic Uses Triamcinolone Retinal Diseases |
