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Triamcinolone vs. Laser for Diabetic Macular Edema (IVTA)

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ClinicalTrials.gov Identifier: NCT00229931
Recruitment Status : Completed
First Posted : September 30, 2005
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Tracking Information
First Submitted Date  ICMJE September 28, 2005
First Posted Date  ICMJE September 30, 2005
Results First Submitted Date  ICMJE April 10, 2017
Results First Posted Date  ICMJE July 28, 2017
Last Update Posted Date July 28, 2017
Study Start Date  ICMJE November 2005
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2010)
Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost. [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2005)
Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost.
Change History Complete list of historical versions of study NCT00229931 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2010)
Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage. [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2005)
Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Triamcinolone vs. Laser for Diabetic Macular Edema
Official Title  ICMJE The Role of Triamcinolone Injection During Cataract Extraction for Diabetic Patients With Pre-Operative Macular Edema
Brief Summary

The purpose of this study is to determine if intravitreal triamcinolone acetonide (IVTA) injection at the time of cataract surgery will improve visual acuity and decrease post-operative swelling in diabetic patients requiring cataract extraction as compared to the conventional treatment of laser following cataract surgery.

The subjects will be followed for 11 visits over 3 year. Visits will occur at screening,1, 3,6,9,12,18,24,30 and 36 months post surgery.

Detailed Description

Protocol Summary:

This is a randomized, prospective study comparing diabetic patients with pre-operative macular edema undergoing cataract surgery treated with either 4 mg of intravitreal triamcinolone at the time of cataract surgery or focal laser treatment 1 month following cataract surgery.

Disease State:

The conventional treatment for clinically significant macular edema is focal laser photocoagulation. In some diabetic patients however, the cataract often impedes fundus visualization for optimal laser treatment. In these patients focal laser treatment is deferred until after cataract surgery.

Study aim:

The purpose of this study is to determine if intravitreal triamcinolone acetonide (IVTA) injection at the time of cataract surgery will improve visual acuity and decrease post-operative macular edema in diabetic patients with pre-operative macular edema requiring cataract extraction as compared to the conventional treatment of focal laser photocoagulation following cataract surgery.

Hypothesis:

We propose that by injecting triamcinolone intravitreally at the time of cataract surgery in patients who have pre-operative macular edema, we will not only reduce the risk of exacerbating macular edema but also possibly improve the final visual outcome.

Study Procedures:

After informed consent is obtained each patient will be placed, based on a randomization scheme, into either the control group receiving the conventional focal laser treatment one month following cataract extraction or into the study group receiving the IVTA injection at the time of surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE DIABETIC MACULAR EDEMA
Intervention  ICMJE
  • Drug: Triamcinolone acetonide
    4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response
    Other Name: Kenalog
  • Procedure: laser
    Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.
    Other Name: focal laser photocoagulation
Study Arms  ICMJE
  • Active Comparator: Laser therapy
    If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.
    Intervention: Procedure: laser
  • Active Comparator: Triamcinolone therapy
    At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered "treatment failure" and will be given the option to have laser therapy.
    Intervention: Drug: Triamcinolone acetonide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2014)
11
Original Enrollment  ICMJE
 (submitted: September 28, 2005)
40
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • visually significant cataracts
  • pre-operative visual acuity 20/50 or worse
  • pre-operative optical coherence tomography (OCT) showing at least 250 microns central foveal thickness.

Exclusion Criteria:

  • macular ischemia
  • vitreomacular traction
  • macular hole
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00229931
Other Study ID Numbers  ICMJE 2746
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert E Leonard, MD Dean A. McGee Eye Institute
PRS Account University of Oklahoma
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP