NEWS HIGHLIGHTS
Published Studies Related to Nasacort (Triamcinolone Nasal)
Efficacy and safety of triamcinolone acetonide aqueous nasal spray in children aged 2 to 5 years with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled study with an open-label extension. [2009.04]
BACKGROUND: Intranasal corticosteroids (INSs) are the most effective treatment for allergic rhinitis (AR). However, available INS safety and efficacy data in children younger than 6 years are limited. OBJECTIVE: To report the first well-controlled study assessing the safety and efficacy of an INS in children aged 2 to 5 years with perennial AR... CONCLUSIONS: Use of TAA AQ, 110 microg once daily, for up to 6 months offers a favorable efficacy to safety ratio in children aged 2 to 5 years with perennial AR.
Comparison of intranasal hypertonic dead sea saline spray and intranasal aqueous triamcinolone spray in seasonal allergic rhinitis. [2005.07]
Intranasal corticosteroids are well known to be efficacious in the treatment of allergic rhinitis. Nasal irrigation with saline, including hypertonic saline, has long been recommended for the treatment of sinonasal disease, and it has been shown to have a positive effect on the physiology of the nasal mucosa...
Effect on growth of long-term treatment with intranasal triamcinolone acetonide aqueous in children with allergic rhinitis. [2008.10]
BACKGROUND: Guidelines recommend treatment with intranasal corticosteroids for patients with allergic rhinitis (AR), but concerns remain about possible adverse effects. OBJECTIVE: To present the 1- and 2-year growth results for children with AR treated with triamcinolone acetonide aqueous nasal spray... CONCLUSIONS: Triamcinolone acetonide aqueous titered to control AR symptoms and given for 1 or 2 years had no significant effect on statural growth in children with AR.
Optical coherence tomographic pattern may predict visual outcome after intravitreal triamcinolone for diabetic macular edema. [2007.05]
OBJECTIVE: To identify an optical coherence tomography (OCT) pattern predictive of visual outcome in patients with diabetic macular edema (DME) who underwent a single dose of intravitreal triamcinolone. DESIGN: Retrospective case analysis with prospective data collection for controls. PARTICIPANTS: Ninety-three cases and 25 controls... CONCLUSIONS: Patients in whom OCT demonstrated the high reflectivity of inner retinal layers achieved greater VA though macular thickness decreased significantly after intravitreal triamcinolone in both groups. It may be hypothesized that a lower optical reflectivity of inner retinal layers is related to the atrophy of the inner retinal layers, thus resulting in a failure of VA recovery in these patients. The level of reflectivity from inner retinal layers on OCT may provide objective criteria in predicting the response of DME to intravitreal triamcinolone and help in preoperative counseling of patients with DME.
Triamcinolone acetonide-induced ocular hypertension. [2006.08]
PURPOSE: The aim of this study is to report on the clinical course of a patient showing markedly increased intraocular pressure (IOP) caused by intravitreal triamcinolone acetonide... CONCLUSIONS: Relatively young patients with a pronounced TA-induced rise in IOP, unresponsive to maximal antiglaucomatous medication, may not necessarily undergo antiglaucomatous surgery if the rise in IOP does not last longer than approximately 3 months.
Clinical Trials Related to Nasacort (Triamcinolone Nasal)
A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema [Completed]
The study involves the enrollment of patients over 18 years of age with diabetic macular
edema involving the center of the macula who have not already been given maximal laser
treatment.
Patients with one study eye will be randomly assigned (stratified by prior laser) with equal
probability to one of five treatment groups:
1. Focal laser photocoagulation (modified ETDRS technique)
2. Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
3. Anterior peribulbar injection of 20 mg triamcinolone
4. Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser
5. Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser
For patients with two study eyes (both eyes eligible at the time of randomization), the right
eye (stratified by prior laser) will be randomly assigned with equal probabilities to one of
the five treatment groups listed above. If the right eye was assigned to laser only, then the
left eye will be assigned to one of the four triamcinolone groups above with equal
probability (stratified by prior laser). If the right eye was assigned to receive
triamcinolone, then the left eye will receive laser only.
Triamcinolone acetonide will be the corticosteroid utilized in this study. The triamcinolone
acetonide preparation to be used is Kenalog. Kenalog is manufactured by Bristol Myers Squibb
and is approved by the Food and Drug Administration for intramuscular use for a variety of
indications. Peribulbar injections of Kenalog have been used for a wide variety of ocular
conditions, particularly uveitis and post-cataract extraction cystoid macular edema, for many
years.
Two different triamcinolone regimens will be assessed in the study: 40 mg injected
posteriorly and 20 mg injected anteriorly. There is no indication of which treatment regimen
will be better. Although the injection behind the eye is more common than the injection near
the front of the eye, the injection near the front of the eye has less risk of injuring the
eye. However, it is possible that the injection near the front of the eye may increase eye
pressure more frequently. Little is known about which of the two injections decreases macular
edema and improves vision more often.
Patients enrolled into the study will be followed for three years and will have study visits
1 month, 2 months, 4 months, 8 months and annually after receiving their assigned study
treatment. For the first 8 months of the study, patients should only be retreated with their
randomized treatment. However, if the patient's visual acuity has decreased by 15 letters or
more, then any treatment may be given at the investigator's discretion. After completion of
the 8-month visit, treatment is at investigator discretion.
The primary objective of this study is to obtain estimates of efficacy and safety outcomes
for each of the treatment groups. These estimates will provide a basis for the sample size
estimation and hypothesis generation in a phase III trial.
Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema [Active, not recruiting]
The study involves the enrollment of patients over 18 years of age with diabetic macular
edema. Patients with one study eye will be randomly assigned (stratified by visual acuity and
prior laser) with equal probability to one of the three treatment groups:
1. Laser photocoagulation
2. 1mg intravitreal triamcinolone acetonide injection
3. 4mg intravitreal triamcinolone acetonide injection
For patients with two study eyes (both eyes eligible at the time of randomization), the right
eye (stratified by visual acuity and prior laser) will be randomly assigned with equal
probabilities to one of the three treatment groups listed above. The left eye will be
assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned
to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with
equal probability (stratified by visual acuity and prior laser).
The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal
injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will
receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will
be better.
Patients enrolled into the study will be followed for three years and will have study visits
every 4 months after receiving their assigned study treatment. In addition, standard of care
post-treatment visits will be performed at 4 weeks after each intravitreal injection.
Study Of Combined VISUDYNE Therapy With Kenalog In CNV Secondary To Age-Related Macular Degeneration [Completed]
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.
Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR) [Recruiting]
The primary objective of the study is to characterize the difference in prepubescent growth
velocity in children 3 to 9 years of age with PAR treated with TAA nasal spray (NASACORT AQ
110 μg treatment group) or placebo (NASACORT AQ placebo group) for 12-months.
Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study [Active, not recruiting]
This open label extension will treat all the eyes of study participants with active study
medication (intravitreal triamcinolone) as well as standard laser treatment where
appropriate.
The specific aims will be to test the following hypotheses:
- That intravitreal triamcinolone for diabetic macular oedema that persists or recurs
after laser treatment remains efficacious over five years
- That intravitreal triamcinolone for diabetic macular oedema that persists or recurs
after laser treatment retains a manageable and acceptable safety profile over five
years
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