NCT00371410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 4, 2006

Status Verified

August 1, 2006

First QC Date

August 31, 2006

Last Update Submit

August 31, 2006

Conditions

Diabetic Macular Edema

Keywords

VitrectomyIntravitreal triamcinolone acetonideMacular focal laser photocoagulationBest-corrected visual acuityCentral macular thickness

Outcome Measures

Primary Outcomes (2)

  • Best-corrected visual acuity

  • Central macular thickness

Interventions

vitrectomyPROCEDURE
intravitreal triamcinolone acetonideDRUG
macular focal laser photocoagulationPROCEDURE

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • Kang SW, Park SC, Cho HY, Kang JH. Triple therapy of vitrectomy, intravitreal triamcinolone, and macular laser photocoagulation for intractable diabetic macular edema. Am J Ophthalmol. 2007 Dec;144(6):878-885. doi: 10.1016/j.ajo.2007.07.044. Epub 2007 Oct 15.

    PMID: 17936715DERIVED

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Se Woong Kang, MD

    Samsung Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 4, 2006

Study Start

April 1, 2005

Study Completion

October 1, 2007

Last Updated

September 4, 2006

Record last verified: 2006-08

Locations

KR(1)