May 2005
Volume 46, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2005
A Randomized, Placebo–Controlled Trial of Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema That Persists or Recurs After Laser Treatment – 2–Year Results
Author Affiliations & Notes
  • M.C. Gillies
    Ophthatlmology,
    University of Sydney, Sydney, Australia
  • M. Zhu
    Ophthatlmology,
    University of Sydney, Sydney, Australia
  • J.M. Simpson
    Ophthatlmology,
    School of Public Health,
    University of Sydney, Sydney, Australia
  • F.K. P. Sutter
    Ophthatlmology,
    University of Sydney, Sydney, Australia
  • Footnotes
    Commercial Relationships  M.C. Gillies, Regenera P; M. Zhu, None; J.M. Simpson, None; F.K.P. Sutter, None.
  • Footnotes
    Support  Juvenile Diabetes Research Foundation, Ophthalmic Research Institute of Australia
Investigative Ophthalmology & Visual Science May 2005, Vol.46, 4672. doi:
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    • Get Citation

      M.C. Gillies, M. Zhu, J.M. Simpson, F.K. P. Sutter; A Randomized, Placebo–Controlled Trial of Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema That Persists or Recurs After Laser Treatment – 2–Year Results . Invest. Ophthalmol. Vis. Sci. 2005;46(13):4672.

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

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Abstract
 
Abstract:
 

To study the safety and efficacy of an intravitreal injection of triamcinolone acetonide (IVTA) for diabetic macular edema that persists or recurs after laser treatment.

 

Eyes were randomised to receive 4mg of IVTA or subconjunctival saline up to every 6 months with laser treatment if appropriate according to a prospectively identified treatment paradigm. The main outcome measures were improvement of best–corrected LogMAR visual acuity by 5 or more letters and incidence of moderate or severe adverse events.

 

69 eyes of 43 patients participated, with 34 eyes randomized to receive active treatment and 35 placebo. 64/69 (93%) eyes were still participating in the study when the data were analysed in September 2004, by which time 15 IVTA–treated eyes and 13 placebo–treated eyes had completed the 2–year study visit. Elevation of the intraocular pressure (IOP) by 5 or more mmHg was recorded in 21/33 (64%) IVTA–treated vs. 3/31 (9%) placebo–treated eyes. Trabeculectomy was required in 1/33 (3%) triamcinolone–treated eyes. Topical therapy was required and otherwise sufficient in 14/33 (42%) triamcinolone–treated vs. 1/31 (3%) placebo–treated eyes. Significant progression of cataract was noted in 12/33 (36%) IVTA–treated vs. 3/31 (9%) placebo–treated eyes. 13/33 (39%) IVTA–treated eyes underwent cataract surgery. One IVTA–treated eye developed infectious endophthalmitis which was adequately treated without loss of visual acuity.

 

 

Table: 2–year visual acuity results from the 28 eyes of 18 patients that had completed the 2–year study visit by Sep 04. The 2–year results for all study participants will be available in March 2005.

 

The short term efficacy of intravitreal triamcinolone which we have previously reported for eyes with diabetic macular edema that have failed laser treatment appears to persist for up to 2 years with ongoing treatment as required. The safety profile of IVTA for diabetic macular edema is significant but appears to be manageable.

 

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