May 2008
Volume 49, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2008
Intravitreal Triamcinolone for Refractory Diabetic Macular Oedema: 5-Year Results of a Double-Masked, Placebo-Controlled, Randomised Clinical Trial With Open Label Extension
Author Affiliations & Notes
  • M. C. Gillies
    Ophthatlmology, University of Sydney, Sydney, Australia
  • Footnotes
    Commercial Relationships  M.C. Gillies, patent relating to formulation of triamcinolone for intraocular use, P; Allergan (Posurdex), R.
  • Footnotes
    Support  Ophthalmic Research Institute of Australia, Juvenile Diabetes Research Foundation, Sydney Eye Hospital Foundation
Investigative Ophthalmology & Visual Science May 2008, Vol.49, 1565. doi:https://doi.org/
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      M. C. Gillies; Intravitreal Triamcinolone for Refractory Diabetic Macular Oedema: 5-Year Results of a Double-Masked, Placebo-Controlled, Randomised Clinical Trial With Open Label Extension. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1565. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : To report the results of a preliminary analysis of 5-year safety and efficacy outcomes from a 2-year double-masked, placebo-controlled, randomised clinical trial with 3 year open-label extension of intravitreal triamcinolone acetonide (IVTA) injections (4mg) in eyes with refractory diabetic macular edema.

Methods: : 69 eyes of 43 patients were entered into the study, with 34 eyes randomized to receive active treatment and 35 placebo. Five-year data were available for 52/69 (75%) eyes of 33/41 (80%) patients. Eyes randomized to initial placebo received a subconjunctival injection of saline. After 2 years, all patients, including those initially randomized to placebo, received treatment with IVTA if there was persistent impairment of vision with central macular thickness (CMT) > 275 micron. Main outcome measures were Improvement of best-corrected LogMAR (Logarithm of Minimum Angle of Resolution) visual acuity by 5 or more letters and incidence of moderate or severe adverse events. Data from eyes with missing 5 year data were treated as Last Observation Carried Forward.

Results: : During the third year or the study when all eyes were eligible for treatment, a similar proportion of eyes from the 2 groups had macular edema with persistent impairment of vision that warranted further treatment with IVTA: initial-IVTA, 12/29 (41%); initial-placebo, 10/28 (36%). The mean visual acuity score at baseline was 59.2 and at 5 years 62.8 letters in the initial-IVTA group. The mean visual acuity score at baseline was 59.7 and 58.3 at 5 years in the initial placebo group. The mean reduction in CMT was 76 micron in the initial-IVTA group compared with 186 micron in the initial-placebo group. Glaucoma medication was required at some point in 23/26 (88%) initial-IVTA vs 5/26 (19%) initial-placebo eyes. Cataract surgery was performed in 19/26 (73%) initial-IVTA vs 2/26 (8%) initial-placebo eyes. 3 eyes in the initial-IVTA group required trabeculectomy. There was one case of infectious endophthalmitis in the initial-IVTA group.

Clinical Trial: : www.actr.org.au 012605000244606

Keywords: diabetic retinopathy • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • edema 
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