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Safety of an intravitreal injection of triamcinolone: results from a randomized clinical trial.

Abstract

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.

CONCLUSION

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.

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  • Authors+Show Affiliations

    ,

    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

    , , , , , , ,

    Source

    MeSH

    Aged
    Aged, 80 and over
    Cataract
    Choroidal Neovascularization
    Double-Blind Method
    Female
    Glucocorticoids
    Humans
    Injections
    Intraocular Pressure
    Macular Degeneration
    Male
    Middle Aged
    Prospective Studies
    Safety
    Triamcinolone Acetonide
    Visual Acuity
    Vitreous Body

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    15006845

    Citation

    Gillies, Mark C., et al. "Safety of an Intravitreal Injection of Triamcinolone: Results From a Randomized Clinical Trial." Archives of Ophthalmology (Chicago, Ill. : 1960), vol. 122, no. 3, 2004, pp. 336-40.
    Gillies MC, Simpson JM, Billson FA, et al. Safety of an intravitreal injection of triamcinolone: results from a randomized clinical trial. Arch Ophthalmol. 2004;122(3):336-40.
    Gillies, M. C., Simpson, J. M., Billson, F. A., Luo, W., Penfold, P., Chua, W., ... Hunyor, A. B. (2004). Safety of an intravitreal injection of triamcinolone: results from a randomized clinical trial. Archives of Ophthalmology (Chicago, Ill. : 1960), 122(3), pp. 336-40.
    Gillies MC, et al. Safety of an Intravitreal Injection of Triamcinolone: Results From a Randomized Clinical Trial. Arch Ophthalmol. 2004;122(3):336-40. PubMed PMID: 15006845.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Safety of an intravitreal injection of triamcinolone: results from a randomized clinical trial. AU - Gillies,Mark C, AU - Simpson,Judy M, AU - Billson,Frank A, AU - Luo,Wei, AU - Penfold,Philip, AU - Chua,William, AU - Mitchell,Paul, AU - Zhu,Meidong, AU - Hunyor,Alex B L, PY - 2004/3/10/pubmed PY - 2004/3/31/medline PY - 2004/3/10/entrez SP - 336 EP - 40 JF - Archives of ophthalmology (Chicago, Ill. : 1960) JO - Arch. Ophthalmol. VL - 122 IS - 3 N2 - 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. CONCLUSION: 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. SN - 0003-9950 UR - https://www.unboundmedicine.com/medline/citation/15006845/Safety_of_an_intravitreal_injection_of_triamcinolone:_results_from_a_randomized_clinical_trial_ L2 - https://jamanetwork.com/journals/jamaophthalmology/fullarticle/10.1001/archopht.122.3.336 DB - PRIME DP - Unbound Medicine ER -