Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Triamcinolone vs. Laser for Diabetic Macular Edema (IVTA)

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.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition DIABETIC MACULAR EDEMA
Interventions Drug: Triamcinolone acetonide
Procedure: laser
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Laser Therapy Triamcinolone Therapy
Hide Arm/Group Description

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.

laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.

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.

Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response

Period Title: Overall Study
Started 6 5
Completed 2 3
Not Completed 4 2
Reason Not Completed
Death             1             0
Lost to Follow-up             3             2
Arm/Group Title Laser Therapy Triamcinolone Therapy Total
Hide Arm/Group Description

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.

laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.

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.

Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response

Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  83.3%
4
  80.0%
9
  81.8%
>=65 years
1
  16.7%
1
  20.0%
2
  18.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
6
 100.0%
4
  80.0%
10
  90.9%
Male
0
   0.0%
1
  20.0%
1
   9.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 5 participants 11 participants
6 5 11
1.Primary Outcome
Title Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost.
Hide Description [Not Specified]
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to lack of follow up from patients, this outcome was not analyzed; data were not collected
Arm/Group Title Laser Therapy Triamcinolone Therapy
Hide Arm/Group Description:

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.

laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.

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.

Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage.
Hide Description [Not Specified]
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Laser Therapy Triamcinolone Therapy
Hide Arm/Group Description:

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.

laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.

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.

Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Laser Therapy Triamcinolone Therapy
Hide Arm/Group Description

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.

laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.

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.

Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response

All-Cause Mortality
Laser Therapy Triamcinolone Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   2/6 (33.33%)      0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Laser Therapy Triamcinolone Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/5 (0.00%)    
Cardiac disorders     
Cardiac Arrest *  1/6 (16.67%)  1 0/5 (0.00%)  0
Renal and urinary disorders     
Kidney Failure * [1]  1/6 (16.67%)  1 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Shortness of Breath * [2]  1/6 (16.67%)  1 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Patient admitted to hospital for kidney failure
[2]
Patient admitted to hospital for shortness of breath
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Laser Therapy Triamcinolone Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      1/5 (20.00%)    
Eye disorders     
Vitreous Hemorrhage *  0/6 (0.00%)  0 1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
Due to lack of patient follow up on this study, sufficient data was not available for analysis
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert E. Leonard, II, MD
Organization: Dean McGee Eye Institute
Phone: 405-271-6307
EMail: sonny-icks@dmei.org
Layout table for additonal information
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00229931     History of Changes
Other Study ID Numbers: 2746
First Submitted: September 28, 2005
First Posted: September 30, 2005
Results First Submitted: April 10, 2017
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017