Trial Outcomes & Findings for Triamcinolone vs. Laser for Diabetic Macular Edema (NCT NCT00229931)

NCT ID: NCT00229931

Last Updated: 2023-12-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2023-12-28

Participant Flow

Participant milestones

Measure	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. laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.	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. Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response
Overall Study STARTED	6	5
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	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. laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.	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. Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response
Overall Study Death	1	0
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

Triamcinolone vs. Laser for Diabetic Macular Edema

Baseline characteristics by cohort

Measure	Laser Therapy n=6 Participants 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.	Triamcinolone Therapy n=5 Participants 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 n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Due to lack of follow up from patients, this outcome was not analyzed; data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: Data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Laser Therapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 2 deaths

Triamcinolone Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Laser Therapy n=6 participants at risk 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.	Triamcinolone Therapy n=5 participants at risk 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
Cardiac disorders Cardiac Arrest	16.7% 1/6 • Number of events 1	0.00% 0/5
Respiratory, thoracic and mediastinal disorders Shortness of Breath	16.7% 1/6 • Number of events 1	0.00% 0/5
Renal and urinary disorders Kidney Failure	16.7% 1/6 • Number of events 1	0.00% 0/5

Other adverse events

Measure	Laser Therapy n=6 participants at risk 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.	Triamcinolone Therapy n=5 participants at risk 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
Eye disorders Vitreous Hemorrhage	0.00% 0/6	20.0% 1/5 • Number of events 1

Additional Information

Robert E. Leonard, II, MD

Dean McGee Eye Institute

Phone: 405-271-6307

Email: sonny-icks@dmei.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place