NCT01202461

Brief Summary

This study is designed to report 3-year result of triple therapy of vitrectomy, intravitreal triamcinolone and macular laser photocoagulation for intractable diabetic macular edema. Previously author reported 1-year result(Am J Ophthalmol. 2007 Dec;144(6):878-885. Epub 2007 Oct 15.).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2010

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2010

Completed
Last Updated

September 15, 2010

Status Verified

September 1, 2010

Enrollment Period

Same day

First QC Date

September 14, 2010

Last Update Submit

September 14, 2010

Conditions

Diabetic RetinopathyMacular Edema

Keywords

Diabetic macular edemaCombination therapy for DMEDME

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity

    Measurement of visual acuity at every visit. VA at every visit was compared from VA at baseline

    At baseline, 6,12,24,36 months after surgery

Secondary Outcomes (1)

  • Central subfield macular thickness

    0,6,12,24,36 months after surgery

Interventions

Triple therapy of vitrectomy, IVTA and grid/focal laser photocoagulationPROCEDURE

all pars plana vitrectomy were accompanied with removal of retinal Internal limiting membrane (ILM) around fovea in round fashion with a dimension of approximately 2 disc diameters. IVTA was introduced at the end of surgery or on the next day (4mg in 0.1cc). Two weeks afterward, fluorescein angiography guided macular laser photocoagulation which consisted of direct photocoagulation on leaking microaneurysms and application of grid pattern laser was undertaken.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
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)
  • central subfield macular thickness (CST) greater than 250μm

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, S. Korea, 135-710, South Korea

Location

MeSH Terms

Conditions

Diabetic RetinopathyMacular Edema

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesMacular DegenerationRetinal Degeneration

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

September 14, 2010

First Posted

September 15, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

September 15, 2010

Record last verified: 2010-09

Locations

KR(1)