CLINICAL TRIALS PROFILE FOR KENALOG-H

505(b)(2) Clinical Trials for Kenalog-h

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.

All Clinical Trials for Kenalog-h

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00101764 ↗	Intravitreal v. Sub-tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders	Completed	National Eye Institute (NEI)	Phase 1	2005-01-05	The use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be a promising treatment for a variety of ocular diseases associated with inflammation. To date, the only drug available, "Kenalog-40 Injection" produced by Bristol Myers Squibb, has not been formulated for intraocular use. The purpose of this study is to evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide (TAC-PF) at two dosage levels (4 mg and 8 mg) compared to anterior sub-tenon injections of TAC-PF at 20 mg. The study will be a masked, randomized Phase I study that will enroll 120 participants with one of the following diseases: age-related macular degeneration (AMD), diabetic macular edema (DME), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), or any other retinal disease with associated macular edema. At least 21 participants will be enrolled in the four designated disease strata: AMD, DME, CRVO, and BRVO. The remaining 36 participants may have one of these diseases or may be enrolled with another retinal disease. Within each disease strata, at least seven participants will be randomized to each dosing group. The participants will be randomly assigned to one of the three treatment groups. The primary outcome will be an assessment of post-injection intraocular toxicity-related events during the 3-year follow-up, including cataract formation, development of glaucoma, and any adverse event preventing retreatment. The secondary outcomes will be an improvement in best-corrected visual acuity (BCVA, EVA) and decreases in retinal thickening and area of leakage, from baseline to year 1.
NCT00105027 ↗	The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study	Completed	Allergan	Phase 3	2004-10-01	The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
NCT00105027 ↗	The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study	Completed	National Eye Institute (NEI)	Phase 3	2004-10-01	The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
NCT00105027 ↗	The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study	Completed	The Emmes Company, LLC	Phase 3	2004-10-01	The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
NCT00105027 ↗	The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study	Completed	The EMMES Corporation	Phase 3	2004-10-01	The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
NCT00140803 ↗	Study Of Combined VISUDYNE Therapy With Kenalog In CNV Secondary To Age-Related Macular Degeneration	Completed	Novartis	Phase 2	2003-10-01	To determine whether VISUDYNE therapy in combination with 4 mg intravitreal triamcinolone will reduce the average loss from baseline of best corrected visual acuity (BCVA) as compared with Visudyne therapy without intravitreal triamcinolone at 12 months in subjects with occult subfoveal and minimally classic subfoveal CNV secondary to AMD. The intravitreal triamcinolone will be given as either a 1 mg or 4 mg dose. This study will also evaluate the safety of Visudyne therapy in combination with intravitreal triamcinolone. An interim statistical readout will be performed when the first 60 patients have completed 6 months of follow-up evaluation.

Clinical Trial Conditions for Kenalog-h

Condition Name

Condition Name for Kenalog-h
Intervention	Trials
Diabetic Macular Edema	4
Shoulder Pain	4
Retinal Vein Occlusion	4
Knee Osteoarthritis	3

Condition MeSH

Condition MeSH for Kenalog-h
Intervention	Trials
Osteoarthritis	10
Macular Edema	10
Osteoarthritis, Knee	8
Edema	8

Clinical Trial Locations for Kenalog-h

Trials by Country

Trials by Country for Kenalog-h
Location	Trials
United States	128
Canada	9
United Kingdom	2
Mexico	2
China	2

Trials by US State

Trials by US State for Kenalog-h
Location	Trials
California	11
Pennsylvania	9
Florida	7
Texas	7
Utah	6

Clinical Trial Progress for Kenalog-h

Clinical Trial Phase

Clinical Trial Phase for Kenalog-h
Clinical Trial Phase	Trials
Phase 4	22
Phase 3	11
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Kenalog-h
Clinical Trial Phase	Trials
Completed	33
Recruiting	10
Terminated	9

Clinical Trial Sponsors for Kenalog-h

Sponsor Name

Sponsor Name for Kenalog-h
Sponsor	Trials
National Eye Institute (NEI)	6
Flexion Therapeutics, Inc.	3
Milton S. Hershey Medical Center	3

Sponsor Type

Sponsor Type for Kenalog-h
Sponsor	Trials
Other	88
Industry	17
NIH	8