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A randomized clinical trial of a single dose of intravitreal triamcinolone acetonide for neovascular age-related macular degeneration: one-year results.

Abstract

OBJECTIVE

To determine if a single intravitreal injection of 4 mg of triamcinolone acetonide in patients with classic choroidal neovascularization associated with age-related macular degeneration can safely reduce the risk of severe visual loss.

METHODS

A double-masked, placebo-controlled, randomized clinical trial was performed in patients 60 years or older who had choroidal neovascularization with any classic component, a duration of symptoms of less than 1 year, and a visual acuity of 20/200 or better. Best-corrected visual acuity, intraocular pressure, and cataract grading were performed before the injection and then at 3, 6, and 12 months.

MAIN OUTCOME MEASURE

The development of severe loss of vision (30 letters) by survival analysis on an intention-to-treat basis.

RESULTS

One hundred fifty-one eyes were randomized into the study, and follow-up data were obtained for 73 (97%) of the 75 eyes in the treated group and for 70 (92%) of the 76 eyes in the control group. There was no difference between the 2 groups for the development of severe visual loss during the first year of the study (log-rank chi 2(1) = 0.03, P =.90). In both groups, the 12-month risk of severe visual loss was 35%, with a hazard ratio of 1.05 (95% confidence interval, 0.59-1.86). The change in size of the neovascular membranes, however, was significantly less in eyes receiving triamcinolone than in those receiving placebo 3 months after treatment (P =.01), although no difference was noted after 12 months. After 12 months, treated eyes had a significantly higher risk of an elevated intraocular pressure (31/75 [41%] vs 3/76 [4%]; P<.001), but not of cataract progression (P =.29).

CONCLUSIONS

A single dose of intravitreal triamcinolone had no effect on the risk of loss of visual acuity during the first year of the study in eyes with age-related macular degeneration and classic choroidal neovascularization, despite a significant antiangiogenic effect found 3 months after treatment. This biological effect warrants further study.

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  • Authors+Show Affiliations

    ,

    Save Sight and Eye Health Institute, and the Department of Clinical Ophthalmology, University of Sydney, New South Wales, Australia. mark@eye.usyd.edu.au

    , , , , , ,

    Source

    MeSH

    Aged
    Choroidal Neovascularization
    Double-Blind Method
    Female
    Fluorescein Angiography
    Glucocorticoids
    Humans
    Injections
    Intraocular Pressure
    Macular Degeneration
    Male
    Prospective Studies
    Safety
    Triamcinolone Acetonide
    Vision Disorders
    Visual Acuity
    Vitreous Body

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    12742844

    Citation

    Gillies, Mark C., et al. "A Randomized Clinical Trial of a Single Dose of Intravitreal Triamcinolone Acetonide for Neovascular Age-related Macular Degeneration: One-year Results." Archives of Ophthalmology (Chicago, Ill. : 1960), vol. 121, no. 5, 2003, pp. 667-73.
    Gillies MC, Simpson JM, Luo W, et al. A randomized clinical trial of a single dose of intravitreal triamcinolone acetonide for neovascular age-related macular degeneration: one-year results. Arch Ophthalmol. 2003;121(5):667-73.
    Gillies, M. C., Simpson, J. M., Luo, W., Penfold, P., Hunyor, A. B., Chua, W., ... Billson, F. (2003). A randomized clinical trial of a single dose of intravitreal triamcinolone acetonide for neovascular age-related macular degeneration: one-year results. Archives of Ophthalmology (Chicago, Ill. : 1960), 121(5), pp. 667-73.
    Gillies MC, et al. A Randomized Clinical Trial of a Single Dose of Intravitreal Triamcinolone Acetonide for Neovascular Age-related Macular Degeneration: One-year Results. Arch Ophthalmol. 2003;121(5):667-73. PubMed PMID: 12742844.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A randomized clinical trial of a single dose of intravitreal triamcinolone acetonide for neovascular age-related macular degeneration: one-year results. AU - Gillies,Mark C, AU - Simpson,Judy M, AU - Luo,Wei, AU - Penfold,Philip, AU - Hunyor,Alex B L, AU - Chua,William, AU - Mitchell,Paul, AU - Billson,Frank, PY - 2003/5/14/pubmed PY - 2003/6/5/medline PY - 2003/5/14/entrez SP - 667 EP - 73 JF - Archives of ophthalmology (Chicago, Ill. : 1960) JO - Arch. Ophthalmol. VL - 121 IS - 5 N2 - OBJECTIVE: To determine if a single intravitreal injection of 4 mg of triamcinolone acetonide in patients with classic choroidal neovascularization associated with age-related macular degeneration can safely reduce the risk of severe visual loss. METHODS: A double-masked, placebo-controlled, randomized clinical trial was performed in patients 60 years or older who had choroidal neovascularization with any classic component, a duration of symptoms of less than 1 year, and a visual acuity of 20/200 or better. Best-corrected visual acuity, intraocular pressure, and cataract grading were performed before the injection and then at 3, 6, and 12 months. MAIN OUTCOME MEASURE: The development of severe loss of vision (30 letters) by survival analysis on an intention-to-treat basis. RESULTS: One hundred fifty-one eyes were randomized into the study, and follow-up data were obtained for 73 (97%) of the 75 eyes in the treated group and for 70 (92%) of the 76 eyes in the control group. There was no difference between the 2 groups for the development of severe visual loss during the first year of the study (log-rank chi 2(1) = 0.03, P =.90). In both groups, the 12-month risk of severe visual loss was 35%, with a hazard ratio of 1.05 (95% confidence interval, 0.59-1.86). The change in size of the neovascular membranes, however, was significantly less in eyes receiving triamcinolone than in those receiving placebo 3 months after treatment (P =.01), although no difference was noted after 12 months. After 12 months, treated eyes had a significantly higher risk of an elevated intraocular pressure (31/75 [41%] vs 3/76 [4%]; P<.001), but not of cataract progression (P =.29). CONCLUSIONS: A single dose of intravitreal triamcinolone had no effect on the risk of loss of visual acuity during the first year of the study in eyes with age-related macular degeneration and classic choroidal neovascularization, despite a significant antiangiogenic effect found 3 months after treatment. This biological effect warrants further study. SN - 0003-9950 UR - https://www.unboundmedicine.com/medline/citation/12742844/full_citation L2 - https://jamanetwork.com/journals/jamaophthalmology/fullarticle/vol/121/pg/667 DB - PRIME DP - Unbound Medicine ER -