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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR KENALOG-80


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505(b)(2) Clinical Trials for Kenalog-80

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 Kenalog-80

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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Kenalog-80

Condition Name

Condition Name for Kenalog-80
Intervention Trials
DIABETIC MACULAR EDEMA 4
Shoulder Pain 4
Retinal Vein Occlusion 4
Knee Osteoarthritis 3
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Condition MeSH

Condition MeSH for Kenalog-80
Intervention Trials
Osteoarthritis 10
Macular Edema 10
Edema 8
Osteoarthritis, Knee 8
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Clinical Trial Locations for Kenalog-80

Trials by Country

Trials by Country for Kenalog-80
Location Trials
United States 128
Canada 9
China 2
United Kingdom 2
Mexico 2
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Trials by US State

Trials by US State for Kenalog-80
Location Trials
California 11
Pennsylvania 9
Florida 7
Texas 7
Utah 6
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Clinical Trial Progress for Kenalog-80

Clinical Trial Phase

Clinical Trial Phase for Kenalog-80
Clinical Trial Phase Trials
Phase 4 22
Phase 3 11
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Kenalog-80
Clinical Trial Phase Trials
Completed 33
Recruiting 10
Terminated 9
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Clinical Trial Sponsors for Kenalog-80

Sponsor Name

Sponsor Name for Kenalog-80
Sponsor Trials
National Eye Institute (NEI) 6
Flexion Therapeutics, Inc. 3
Milton S. Hershey Medical Center 3
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Sponsor Type

Sponsor Type for Kenalog-80
Sponsor Trials
Other 88
Industry 17
NIH 8
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Kenalog-80: Clinical Trials, Market Analysis, and Projections

Introduction

Kenalog-80, a formulation of triamcinolone acetonide, is a long-acting corticosteroid used for various medical conditions, including allergic states, dermatologic diseases, and rheumatic disorders. This article will delve into the clinical trials, market analysis, and projections for Kenalog-80.

Clinical Indications and Uses

Kenalog-80 Injection is indicated for intramuscular use in several clinical scenarios:

  • Allergic States: Control of severe or incapacitating allergic conditions such as asthma, atopic dermatitis, and seasonal allergic rhinitis[1][4][5].
  • Dermatologic Diseases: Treatment of conditions like bullous dermatitis herpetiformis, exfoliative erythroderma, and severe erythema multiforme (Stevens-Johnson syndrome)[1][4][5].
  • Rheumatic Disorders: Adjunctive therapy for short-term administration in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, and rheumatoid arthritis, including juvenile rheumatoid arthritis[1][4][5].

Clinical Trials and Efficacy

Clinical trials have demonstrated the efficacy of Kenalog-80 in managing various conditions:

  • Adrenal Suppression: Studies indicate that adrenal suppression occurs within 24-48 hours after a single intramuscular dose of 60-100 mg of triamcinolone acetonide and gradually returns to normal in 30-40 days[2][5].
  • Rheumatic Conditions: Kenalog-80 has been shown to be effective as adjunctive therapy for short-term administration in acute episodes of rheumatic disorders such as acute gouty arthritis and rheumatoid arthritis[1][4][5].
  • Safety Concerns: While effective, corticosteroids like Kenalog-80 can increase the risk of infections, reactivate latent infections, and cause other adverse effects such as increased intraocular pressure and visual disturbances if administered incorrectly[1][2][4].

Market Analysis

Current Market Position

Kenalog-80 is a well-established product in the corticosteroid market, particularly for its long-acting properties and broad range of indications. It is widely used in both hospital and outpatient settings.

Competitors

The corticosteroid market is competitive, with several other long-acting and short-acting corticosteroids available. However, Kenalog-80's specific formulation and extended duration of action give it a unique position in the market.

Market Trends

The demand for corticosteroids is driven by the prevalence of allergic and inflammatory conditions. With an increasing global population and rising healthcare needs, the market for corticosteroids, including Kenalog-80, is expected to grow.

Projections and Future Outlook

Market Growth

The corticosteroid market is projected to grow due to the increasing incidence of chronic diseases such as asthma, arthritis, and autoimmune disorders. Kenalog-80, with its established efficacy and long-acting properties, is likely to maintain its market share and potentially grow as healthcare providers seek effective treatments for these conditions.

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics of pharmaceuticals. Given the established safety and efficacy profile of Kenalog-80, it is expected to continue meeting regulatory standards, ensuring its availability in the market.

Potential Risks and Challenges

Despite its benefits, Kenalog-80 faces challenges such as the risk of adverse effects, particularly with long-term use. Monitoring for infections, reactivation of latent infections, and other complications is essential. Additionally, the emergence of new treatments or biosimilars could potentially impact its market share.

Safety and Precautions

Adverse Effects

Kenalog-80 can cause several adverse effects, including:

  • Adrenal Suppression: Long-term use can lead to adrenal insufficiency, requiring supportive dosage during stress situations[1][4][5].
  • Infections: Increased risk of new infections, exacerbation of existing infections, and reactivation of latent infections such as tuberculosis and hepatitis B[1][4][5].
  • Ocular Complications: Intraocular administration is not recommended due to potential toxicity and complications like increased intraocular pressure and visual disturbances[1][2][4].

Contraindications

  • Live Vaccines: Administration of live or live, attenuated vaccines is contraindicated in patients receiving Kenalog-80 due to immunosuppression[4].
  • Systemic Fungal Infections: Use in the presence of systemic fungal infections is generally avoided unless necessary to control drug reactions[4].

Key Takeaways

  • Clinical Indications: Kenalog-80 is used for a variety of allergic, dermatologic, and rheumatic conditions.
  • Efficacy: Demonstrated effectiveness in clinical trials, particularly for short-term management of acute episodes.
  • Market Position: Established product with a unique long-acting formulation.
  • Growth Projections: Expected to grow due to increasing demand for corticosteroids.
  • Safety Considerations: Requires careful monitoring for adverse effects and contraindications.

FAQs

What are the primary indications for Kenalog-80?

Kenalog-80 is indicated for the treatment of severe allergic conditions, dermatologic diseases, and rheumatic disorders, including asthma, atopic dermatitis, and rheumatoid arthritis.

What are the potential risks associated with Kenalog-80?

Potential risks include adrenal suppression, increased risk of infections, reactivation of latent infections, and ocular complications if administered incorrectly.

Can Kenalog-80 be used in patients with systemic fungal infections?

Kenalog-80 should be avoided in patients with systemic fungal infections unless necessary to control drug reactions, and even then, with caution and potential dosage reduction.

How long does adrenal suppression last after a single dose of Kenalog-80?

Adrenal suppression typically occurs within 24-48 hours after a single dose and gradually returns to normal in 30-40 days.

Is Kenalog-80 suitable for use in acute stress situations?

No, Kenalog-80 is not suitable for use in acute stress situations due to its long-acting properties and the need for rapidly acting corticosteroids in such scenarios.

Sources

  1. FDA Label: Kenalog-40 Injection and Kenalog-80 Injection.
  2. Medicines.org.uk: Kenalog Intra-articular / Intramuscular Injection.
  3. Bristol Myers Squibb: Q3 2024 Results Presentation.
  4. FDA Label: Kenalog-40 Injection and Kenalog-80 Injection (2024 update).
  5. DailyMed: Kenalog-40 Injection and Kenalog-80 Injection.

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