Sequentially Combined Vitrectomy, IVTA and Macular Focal Laser Photocoagulation for Diabetic Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00371410
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : September 4, 2006
Information provided by:
Samsung Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Macular Edema Procedure: vitrectomy Drug: intravitreal triamcinolone acetonide Procedure: macular focal laser photocoagulation Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Primary Outcome Measures :
  1. Best-corrected visual acuity
  2. Central macular thickness

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • clinical diagnosis of diabetes mellitus
  • intractable diffuse DME (diffuse DME which did not respond to or recurred after the previous IVTA and/or macular focal laser photocoagulation)
  • the central macular thickness (CMT) greater than 250 μm

Exclusion Criteria:

  • presence of vitreomacular traction
  • a prior history of treatment for the DME within 3 months or vitreoretinal surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00371410

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Study Director: Se Woong Kang, MD Samsung Medical Center

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00371410     History of Changes
Other Study ID Numbers: 2006-05-029
First Posted: September 4, 2006    Key Record Dates
Last Update Posted: September 4, 2006
Last Verified: August 2006

Keywords provided by Samsung Medical Center:
Intravitreal triamcinolone acetonide
Macular focal laser photocoagulation
Best-corrected visual acuity
Central macular thickness

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action