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Last Updated: December 23, 2024

CLINICAL TRIALS PROFILE FOR TRIAMCINOLONE


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505(b)(2) Clinical Trials for TRIAMCINOLONE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00071227 ↗ Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders Completed National Eye Institute (NEI) Phase 1 2003-10-15 This study will evaluate the safety and effectiveness of a new formulation of triamcinolone acetonide for the treatment of retinal blood vessel disorders. Triamcinolone is a steroid drug that decreases inflammation and scarring and is routinely used to treat eye inflammation or swelling. The commercially available form of this drug is associated with potentially harmful side effects thought to be due to preservatives in the preparation. This study will use a formulation that does not contain these potentially harmful preservatives. Preliminary findings from other studies suggest that injection of steroids in the eye can reduce retinal thickening and improve vision. However, they may also cause mild discomfort and lead to vision-threatening conditions. The effects of the drug on the conditions under study in this protocol are not known. Patients with the following conditions involving disorders of retinal blood vessels may be eligible for this study: - Choroidal neovascularization associated with age-related macular degeneration (50 years of age and older) - Macular edema associated with retinal vein occlusion (18 years of age and older) - Diabetic macular edema ((18 years of age and older) Participants undergo the following tests and procedures: - Medical history and physical examination - Eye examination to assess visual acuity (eye chart test) and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils will be dilated with drops for this examination. - Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. - Indocyanine green angiography to identify feeder vessels that may be supplying abnormal blood vessels. This procedure is similar to fluorescein angiography, but uses a green dye and flashes an invisible light. - Optical coherence tomography to measure retinal thickness. This test shines a light into the eye and produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same. - Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to allow examination and photography of the back of the eye. - Triamcinolone acetonide injection to treat the eye. A numbing eye drop, an antibiotic eye drop, and an injected antibiotic are put in the eye before triamcinolone acetonide is injected into the eye's vitreous (jelly-like substance inside the eye). After the injection, the patient lies on his or her back for 30 minutes. An antibiotic eye ointment is used for 2 days following treatment. - Blood tests to measure liver and kidney function. Patients return to the clinic for follow-up visits 1, 4, and 7 days, and 1 month after the first treatment. Patients whose condition does not improve after 3 months do not receive any more injections, but return for eye examinations at least once a year for 3 years. Patients whose condition improves with treatment return for follow-up visits 6 and 9 months after the first injection and then every 6 months for 2 more years. At each visit, a determination is made whether another injection is needed. After each repeat injection, patients return for follow-up visits at 1, 4, and 7 days after the injection.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for TRIAMCINOLONE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000569 ↗ Lung Health Study II Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1993-09-01 To determine if participants with chronic obstructive pulmonary disease, who were assigned to inhaled corticosteroids had a lower rate of decline in lung function and lower incidence of respiratory morbidity compared to participants assigned to placebo.
NCT00000569 ↗ Lung Health Study II Completed University of Minnesota Phase 3 1993-09-01 To determine if participants with chronic obstructive pulmonary disease, who were assigned to inhaled corticosteroids had a lower rate of decline in lung function and lower incidence of respiratory morbidity compared to participants assigned to placebo.
NCT00000569 ↗ Lung Health Study II Completed University of Minnesota - Clinical and Translational Science Institute Phase 3 1993-09-01 To determine if participants with chronic obstructive pulmonary disease, who were assigned to inhaled corticosteroids had a lower rate of decline in lung function and lower incidence of respiratory morbidity compared to participants assigned to placebo.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TRIAMCINOLONE

Condition Name

Condition Name for TRIAMCINOLONE
Intervention Trials
Diabetic Macular Edema 36
Macular Edema 19
Oral Lichen Planus 14
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Condition MeSH

Condition MeSH for TRIAMCINOLONE
Intervention Trials
Macular Edema 80
Edema 63
Osteoarthritis 31
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Clinical Trial Locations for TRIAMCINOLONE

Trials by Country

Trials by Country for TRIAMCINOLONE
Location Trials
United States 513
Canada 43
Egypt 37
India 32
Brazil 21
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Trials by US State

Trials by US State for TRIAMCINOLONE
Location Trials
California 38
Pennsylvania 27
New York 27
Texas 26
Florida 26
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Clinical Trial Progress for TRIAMCINOLONE

Clinical Trial Phase

Clinical Trial Phase for TRIAMCINOLONE
Clinical Trial Phase Trials
Phase 4 103
Phase 3 65
Phase 2/Phase 3 33
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Clinical Trial Status

Clinical Trial Status for TRIAMCINOLONE
Clinical Trial Phase Trials
Completed 205
Unknown status 65
Recruiting 49
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Clinical Trial Sponsors for TRIAMCINOLONE

Sponsor Name

Sponsor Name for TRIAMCINOLONE
Sponsor Trials
Shahid Beheshti University of Medical Sciences 16
Cairo University 14
National Eye Institute (NEI) 14
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Sponsor Type

Sponsor Type for TRIAMCINOLONE
Sponsor Trials
Other 443
Industry 90
NIH 22
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