Safety of an intravitreal injection of triamcinolone: results from a randomized clinical trial.
OBJECTIVE
To determine the safety of a single intravitreal injection of triamcinolone acetonide (4 mg) in patients with subfoveal choroidal neovascularization caused by age-related macular degeneration.


METHODS
A double-masked, placebo-controlled, randomized clinical trial was conducted at a public tertiary referral eye hospital. Patients participating had age-related macular degeneration with evidence of choroidal neovascularization, any part of which was classic; age older than 59 years; and best-corrected visual acuity of 20/200 or better. Eyes were assigned to active study treatment or to placebo. Intraocular pressure and cataract grading were performed every 6 months for 3 years. Adverse events, from mild to vision-threatening or life-threatening, were recorded as procedure-related or corticosteroid-related.


RESULTS
Seventy-five eyes were assigned to study treatment and 76 eyes to placebo. There were no moderate or severe adverse events related to the surgical procedure in either group. Triamcinolone-treated eyes had a significantly increased risk of developing mild or moderate elevation of the intraocular pressure. Topical glaucoma medication reduced intraocular pressure to acceptable levels in all patients. There was significant progression of cataract in the triamcinolone-treated eyes.


CONCLUSIONS
Despite a significant adverse event profile, intravitreal triamcinolone is generally well tolerated by the human eye as long as patients are carefully followed up by their surgeon and treated appropriately, when necessary.
Department of Clinical Ophthalmology, School of Public Health, and Sydney Eye Hospital, University of Sydney, Sydney, New South Wales, Australia. mark@eye.usyd.edu.au
Mark C
MC
Gillies
Judy M
JM
Simpson
Frank A
FA
Billson
Wei
W
Luo
Philip
P
Penfold
William
W
Chua
Paul
P
Mitchell
Meidong
M
Zhu
Alex B L
AB
Hunyor
D000368:Aged; D000369:Aged, 80 and over; D002386:Cataract / Q000503:physiopathology; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007267:Injections; D007429:Intraocular Pressure / Q000187:drug effects; D008268:Macular Degeneration / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012449:Safety; D014222:Triamcinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects; D014792:Visual Acuity / Q000187:drug effects; D014822:Vitreous Body / Q000187:drug effects*
D005938:Glucocorticoids; D014222:Triamcinolone Acetonide