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

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Laser Therapy	Triamcinolone Therapy
Arm/Group Description	If randomized to laser therapy at t...	At time of cataract surgery, will h...
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

Baseline Characteristics

Arm/Group Title		Laser Therapy	Triamcinolone Therapy	Total
Arm/Group Description		If randomized to laser therapy at t...	At time of cataract surgery, will h...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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
United States		6	5	11

Outcome Measures

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.
Description	[Not Specified]
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data

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
Arm/Group Description:	If randomized to laser therapy at t...	At time of cataract surgery, will h...
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.
Description	[Not Specified]
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Data were not collected


Arm/Group Title	Laser Therapy	Triamcinolone Therapy
Arm/Group Description:	If randomized to laser therapy at t...	At time of cataract surgery, will h...
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.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Laser Therapy		Triamcinolone Therapy
Arm/Group Description	If randomized to laser therapy at t...		At time of cataract surgery, will h...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

Due to lack of patient follow up on this study, sufficient data was not available for analysis

More Information

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
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

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