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Intravitreal triamcinolone
acetonide: a “real world” analysis of visual acuity, pressure and outcomes
Victor
Manuel Villegas,
Aaron Samuel Gold, Andrea Wildner, Azeema Latiff, Timothy Garrett Murray
Murray
Ocular Oncology and Retina, Miami, Florida 33143, USA
Correspondence
to: Victor Manuel Villegas. Murray Ocular Oncology and
Retina, 6705
Red Road, Suite 412, Miami, Florida 33143, USA. v.villegas@med.miami.edu
Received: 2014-11-06
Accepted: 2015-07-09
DOI:10.18240/ijo.2016.05.26
Citation: Villegas VM, Gold
AS, Wildner
A, Latiff
A, Murray
TG. Intravitreal
triamcinolone acetonide: a “real world” analysis of visual acuity, pressure and
outcomes. Int J Ophthalmol 2016;9(5):789-791
Dear Sir,
Triamcinolone acetonide
(TA) is worldwide available therapeutic agent that is commonly used throughout
medicine. TA remains a safe and important ophthalmic therapeutic agent even
after the advent of angiogenesis inhibitors[1-2].
Intravitreal TA effectiveness has been demonstrated either alone or combined
with other treatment options[3-4].
Several commercially available TA formulations are being used for intravitreal
injection. TA formulations vary in pH value, particle size, crystallinity,
solubility, dissolution, and flow kinetics both during and after intravitreal
injection[5-9]. All of
which are important for the clinical understanding of the therapeutic effects
and safety profile of the TA preparation being used.
Triesence (Alcon
Pharmaceuticals, Ft. Worth, TX, USA) is a Food and Drug Administration
(FDA) approved preservative-free TA formulation. Triesence use has increased
mainly due to concern over potential toxicity of TA formulations that have a
preservative (e.g. Kenalog)[10-11]. However, safety and
efficacy of intravitreal Triesence remain poorly elucidated. The present study
was designed to compare visual acuity and intraocular pressure (IOP) before and after
intravitreal Triesence for the treatment of cystoid macular edema. Complication
profile was also evaluated.
An institutional review
board-approved
(LCH-3-012015) retrospective cohort study of 1631 consecutive intravitreal TA (Triesence) injections
was undertaken at an ocular oncology and retina practice. The study included
370 patients that were treated with 0.1 mL of TA 40 mg/mL due to cystoid
macular edema detected by spectral-domain optical coherence tomography (SD-OCT; Heidelberg Spectralis,
Germany). Patients with neovascular glaucoma were excluded from our study. All
patients that underwent treatment with intravitreal TA were refractive to
treatment with at least 2 intravitreal bevacizumab 2.5 mg/0.1 mL injections separated
by a 4-week interval. Patients with intraretinal fluid were treated every
6-8wk. Patients were treated with topical glaucoma medications if IOP was above
18 mm Hg
at any clinical evaluation. If IOP was elevated at any evaluation, the patient
underwent intravitreal bevacizumab 2.5 mg/0.5 mL plus addition of a
topical glaucoma agent with follow up in 4wk.
The mean age of the
population was 68 years of age (range 12-89). Sixty-five percent of patients
were male and 35% were female. Radiation maculopathy (50%) was the most common
diagnosis associated to treatment. Mean follow up time was 8.0±1.4mo. Mean time
between injections was 6.7wk. Mean visual acuity at initiation of treatment was
1.08±0.64 logMAR (20/240). Mean visual acuity at last follow up was 0.76±0.58
logMAR (20/115). Mean IOP at initiation of treatment was
14.64±4.0 mm Hg.
Mean IOP at
last follow up was 14.70±4.1 mm Hg.
Statistical analysis
was performed using Student’s t-test. There was a
statistically significant improvement in best-corrected visual acuity from
initiation of treatment to last follow up (P<0.05).
No significant change in IOP was detected in the study (P=1.00). A significant proportion of the
patients (61%) had IOP
below 21 mm Hg
without treatment. All patients who developed IOP over 21 mm Hg (39%) during
treatment were controlled (IOP below 21 mm Hg) with topical
treatment only. Patients using topical treatment were controlled with a mean
1.3±0.6 agents. Mean IOP in patients under topical treatment was
14.00±4.0 mm Hg.
Thirty percent of patients that were on topical glaucoma treatment during
intravitreal TA
therapy had prior diagnosis of glaucoma. All patients with glaucoma had primary
open-angle glaucoma and were controlled with a mean 1.1±0.5 topical agents. No
patient in the study developed uncontrolled glaucoma that required filtrating
or laser surgery. Endophthalmitis, retinal tears, retinal detachment,
pseudoendophthalmitis, and toxic anterior segment syndrome did not develop in
any of our patients.
TA has been extensively
studied and used in ophthalmology to treat a variety of vitreoretinal disorders
including macular edema, angiogenesis, and intraocular inflammation[12-14]. Various
preservative-free TA preparations (e.g. Triesence, Alcon Laboratories,
Inc.; Trivaris, Allergan, Inc.) have been developed due to concerns
over retinal toxicity from the preservative and bactericidal agent benzyl
alcohol[10-11]. Triesence
use has increased significantly because it is the only FDA approved
preservative-free TA commercially available.
A recent study
performed at the Bascom Palmer Eye Institute, Miami, FL, USA showed that Triesence
has different flow rates from TA with benzyl alcohol[6]. Triesence has also demonstrated a significantly
slower dissolution profile and lower free drug level in the vitreous than TA
with benzyl alcohol[5].
These results suggest that intravitreal Triesence may provide a longer
therapeutic duration and less steroid-related complications, such as cataract
and IOP elevation, when compared to an equivalent intravitreal injection of TA
with benzyl alcohol, because these complications are free TA level-dependent[5]. Retinal cytotoxicity of
TA is also crystal size dependent, with larger aggregates being more cytotoxic[9]. TA with benzyl alcohol
has the largest cytotoxicity and crystal aggregates[9]. These studies suggest that different TA
formulations have different safety and efficacy profiles.
Previous reports on
acute infectious endophthalmitis have been a concern for ophthalmologists using
intravitreal TA[15-16].
Noninfectious endophthalmitis has also been reported with multiple TA
formulations including Triesence[17].
In our study, endophthalmitis was not present. Intraocular inflammation,
vitreous opacification, and synechia in the absence of angle rubeosis were not
identified.
Previous studies have
also reported the annual incidence of
severe IOP rise (defined as needing laser or filtrating surgery) between 3.6
and 9.5 per 1000 TA injections[18]. However, data regarding
Triesence IOP rise remains scarce. No patient underwent laser or filtrating
surgery in the study. IOP showed no statistically significant variation under
our treatment protocol. IOP stability might be related to slower
dissolution profile and lower free drug level[5].
Multiple studies have
reported best-corrected visual acuity improvements after treatment with
intravitreal TA alone or in combination for macular edema[19-20]. There was a statistically significant
improvement in best-corrected visual acuity from initiation of treatment to
last follow up in our study. Future studies may elucidate if the effectiveness
among TA preparations are comparable for cystoid macular edema.
Alternatives to newer
TA preparations are also available in the market. Intravitreal implants offer the comfort of extended treatment interval;
however, intravitreal injections give physicians the ability to more
effectively titrate the treatment to the individual. Triesence also allows the
physician to treat patients with less associated cost than newer generation
cortocosteroids implants. However, Triesence continues to be more expensive
that other TA preparations.
Limitations in our
study include: large proportion of patients with macular edema due to radiation
retinopathy, differential follow up schedule, and retrospective nature.
Cataract progression was not evaluated in our study. Prospective studies are
needed to assess for these variables.
TA continues to be an
important therapeutic agent in the management of cystoid macular edema.
Different formulations may have different clinical impact. This study reports
favorable visual outcomes with stable IOP. Close follow up and low threshold for
treatment may have significantly affected IOP control. Randomized studies are
needed to compare Triesence to other TA preparations.
ACKNOWLEDGEMENTS
Conflicts
of Interest: Villegas VM, None; Gold AS, None; Wildner A, None; Latiff A,
None; Murray TG, None.
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