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Triamcinolone Acetonide Injectable

Phase 3FDA approved 2007

Vitrectomy | Small molecule | Ophthalmology |Alcon Inc.|Trials Updated: Jul 10, 2018

Triamcinolone Acetonide Injectable development status

FDA approval Nov 29, 2007 as Triesence
Approval holderAlcon Res
ApplicationNDA022223
Highest phase Phase 3
Registered trials 1 across 1 sponsor since Mar 2009

Triamcinolone Acetonide Injectable target and mechanism

Molecular targetNR3C1
Target classAgonist
ModalitySmall molecule

Also known as Triamcinolone Acetonide Injectable Suspension, Triesence

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment137

FDA Designations

No designations recorded

Triamcinolone Acetonide Injectable clinical trials

Triamcinolone Acetonide Injectable · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00532415Safety and Efficacy of Vitreous Delineating Agent During VitrectomyVitrectomy
COMPLETED60 Analytics
PHASE3COMPLETED
Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy
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Study Endpoints

Primary Endpoints

Change in Mean Visualization Score at Post-Instillation from Pre-Instillation
Day 0

A video image of the posterior segment structures of the eye was taken before instillation of the test product and after. An independent masked reader evaluated the images and graded the degree of visualization on a 5-point scale ranging from 1 to 4 and anchored at the ends by "Not Visible (0)" and "Clearly Delineated (4)." The mean difference was calculated, and a higher number indicated increased visibility.

Intraocular Pressure (IOP)
1 day, 1week, 1 month, 3 month and 6 month post-op visits

Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was \<21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg.

Secondary Endpoints

Anterior Chamber Inflammation (Flare)
1 month, 3 month and 6 month post-op visits
Bleb Appearance
1 day, 1 week, 1 month, 3 month and 6 month post-op visits
Patient Comfort
1 day, 1 week, 1 month, 3 month and 6 month post-op visits
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Study Design & Arms

AllocationNA
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TriamcinoloneEXPERIMENTALApproximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.
Treatment 1(Triesence)EXPERIMENTALglaucoma surgery with 0.2cc Triesence adjunct.
Treatment 2 (balanced salt solution BSS)ACTIVE_COMPARATORglaucoma surgery with balanced salt solution, the standard technique.

Interventions

NameTypeDescription
Triamcinolone Acetonide Injectable SuspensionDRUGApproximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.
TriesenceDRUGAt end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
balanced salt solution BSSDRUGAt end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery eye. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Patients under 18. * Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history...

Countries:United States
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Frequently asked questions about Triamcinolone Acetonide Injectable

What is triamcinolone acetonide injectable?

Triamcinolone acetonide injectable is a small molecule formulation developed by Alcon Inc. (ticker ALC) for use during vitrectomy, a surgical procedure on the eye. It is an investigational product in Phase 3 clinical development in the ophthalmology therapeutic area.

What is triamcinolone acetonide injectable used for in vitrectomy?

Triamcinolone acetonide injectable is being studied for use during vitrectomy, where it is evaluated as a vitreous delineating agent to help visualize the vitreous gel during the surgical procedure. Its development is focused on this ophthalmology indication under Alcon Inc.

What does triamcinolone acetonide injectable target?

Triamcinolone acetonide injectable targets NR3C1, the glucocorticoid receptor, and acts as an agonist at this receptor. NR3C1 agonism is the mechanism associated with this small molecule in its development for use during vitrectomy.

Who makes triamcinolone acetonide injectable?

Triamcinolone acetonide injectable is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor associated with the clinical development of this ophthalmology asset.

What phase is triamcinolone acetonide injectable in?

Triamcinolone acetonide injectable is in Phase 3 clinical development. It is an investigational product and is not described as approved; its development program in vitrectomy includes one completed Phase 3 trial.

What clinical trials is triamcinolone acetonide injectable in?

Triamcinolone acetonide injectable has been studied in one completed Phase 3 trial, NCT00532415, titled Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy. That trial enrolled 60 participants aged 18 years and older and was an uncontrolled study.

Is triamcinolone acetonide injectable the same as triamcinolone acetonide injectable suspension?

Yes, triamcinolone acetonide injectable is also known as triamcinolone acetonide injectable suspension. Both names refer to the same Alcon Inc. product candidate being developed for use during vitrectomy.