NEWS HIGHLIGHTS
Published Studies Related to Mycolog-II (Nystatin / Triamcinolone Topical)
The significance of ethylenediamine hydrochloride dermatitis caused by a "generic" nystatin-triamcinolone II cream. [1988.04]
Generic Myco-Triacet II Cream would seem to be analogous to Mycolog II Cream. However, Myco-Triacet II Cream still contains the common and potent sensitizer, ethylenediamine hydrochloride, which is no longer present in Mycolog II Cream.This is another instance in which a rose by an other name does not smell as sweet.
Clinical Trials Related to Mycolog-II (Nystatin / Triamcinolone Topical)
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.
A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema [Recruiting]
This study is likely to identify an improved and economical treatment for diabetic macular
oedema, one of the commonest causes of blindness both in Australia and the rest of the
world. The specific aims of the study are to test the following hypotheses:
- That intravitreal triamcinolone followed by laser treatment results in a greater
improvement in visual acuity than placebo followed by laser treatment of eyes with
macular oedema secondary to diabetes;
- That intravitreal triamcinolone followed by laser treatment results in greater degree
of resolution of macular oedema than placebo followed by laser treatment of eyes with
macular oedema secondary to diabetes;
- That intravitreal triamcinolone followed by laser treatment results in a reduced
requirement for further laser treatment to control diabetic macular oedema than placebo
followed by laser treatment;
- That intravitreal triamcinolone followed laser has a manageable and acceptable safety
profile in eyes with diabetic macular edema.
Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO [Recruiting]
Treatment of macular edema secondary to central retinal vein occlusion is more effective
with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.
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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