Intravitreal triamcinolone widely used, but evidence base is lacking

February 23, 2006

Use of intravitreal triamcinolone acetonide has quickly gained favor among retinal specialists as a first-line treatment for treatment of macular edema associated with retinal vein occlusion (RVO). However, findings from an evidence-based literature review indicate published data to support what has become a widespread clinical phenomenon are broad but not deep, said Robert Bhisitkul, MD, PhD, at the World Ophthalmology Congress."The purpose of this analysis was to look beyond the clinical impression that this therapy results in improved vision and reduced macular thickness by considering its long- versus short-term clinical effects. Its results show our best available evidence is inconclusive at best, but results of ongoing studies should give us a greater level of confidence in using intravitreal triamcinolone to treat patients with RVO," said Dr. Bhisitkul, professor of clinical ophthalmology, University of California San Francisco, in the United States.

Use of intravitreal triamcinolone acetonide has quickly gained favor among retinal specialists as a first-line treatment for treatment of macular edema associated with retinal vein occlusion (RVO). However, findings from an evidence-based literature review indicate published data to support what has become a widespread clinical phenomenon are broad but not deep, said Robert Bhisitkul, MD, PhD, at the World Ophthalmology Congress.

"The purpose of this analysis was to look beyond the clinical impression that this therapy results in improved vision and reduced macular thickness by considering its long- versus short-term clinical effects. Its results show our best available evidence is inconclusive at best, but results of ongoing studies should give us a greater level of confidence in using intravitreal triamcinolone to treat patients with RVO," said Dr. Bhisitkul, professor of clinical ophthalmology, University of California San Francisco, in the United States.

Twenty-six published reports identified using a variety of standard electronic resources and that met preset selection criteria were reviewed and rated using the American Academy of Ophthalmology schema for ranking levels of evidence in evaluation of clinical studies. None of the 26 reports met the level 1 criteria, and the bulk (20 papers, 77%) were level 3. In aggregate, the majority of papers had 6 months of follow-up or less and included small patient populations ranging between 1 and less than 10.

Studies underway evaluating intravitreal corticosteroids for the treatment of macular edema in RVO include:

  • The National Eye Institute Standard Care versus COrticosteroid for REtinal Vein Occlusion (SCORE) study, a phase III, randomized study with expected enrollment of 1,260 patients with branch or central retinal vein occlusion;
  • The Allergan-sponsored phase III study of the dexamethasone implant (Posurdex, Oculex Pharmaceuticals/Allergan) in subjects with central or branch RVO;
  • The Manhattan Eye, Ear & Throat Hospital/Alcon Laboratories nonrandomized, open-label, phase II trial of anecortave acetate (Retaane); and
  • The National Eye Institute Intravitreal versus Sub-Tenon Injections of Triamcinolone Acetonide for Macular Edema in retinal disorders. This study is a phase I trial and includes patients with RVO, among other diagnoses.