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Study will investigate triamcinolone for RVO, surgeon says
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NEW YORK — A formulation of triamcinolone specifically for intraocular use will begin trials shortly in patients with retinal vein occlusion, said Michael Ip, MD, here at the Ocular Surgery News Symposium: Cataract, Glaucoma & Refractive Surgery.
The Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) study, funded by the National Eye Institute in 2003, will be a randomized, controlled, multicenter trial designed to gather definitive data on the potential benefits and risks of intraocular triamcinolone, Dr. Ip said.
“Triamcinolone injections are used frequently among ophthalmologists,” he said, but there is “no definitive data on safety or efficacy, especially long-term.”
Using triamcinolone intraocularly is currently an off-label use, as it is labeled for use intramuscularly, he said. Potential ocular problems with Kenalog (triamcinolone acetonide, Bristol Myers Squibb) are that it may cause a sterile endophthalmitis that is “difficult to distinguish from infectious endophthalmitis” and that its excipients include benzyl alcohol, carboxymethylcellulose and polysorbate 80, Dr. Ip said.
For the SCORE study, Dr. Ip said, a new formulation of the drug, manufactured by Allergan, will be used. Patients will be randomly assigned to 4 mg or 1 mg dosing of triamcinolone or standard care for treatment of macular edema associated with central retinal vein occlusion and branch retinal vein occlusion. All patients involved must be at least 18 and have center-involved macular edema due to CRVO or BRVO for at least 3 months but not longer than 18 months.
“If the results from this study are positive, it may result in a new treatment for retinal vein occlusion. If the results are negative, it will discourage the use of a commonly used treatment,” Dr. Ip said.