Endophthalmitis rates low in ongoing intravitreal steroid trials
WAIKOLOA, Hawaii Endophthalmitis rates after triamcinolone injections in the SCORE and DRCR.net trials are low and comparable to those encountered with anti-VEGF injections, a surgeon reported here.
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"As of September 30, there have been over 2,600 injections and only one culture-proven endophthalmitis, for a rate of endophthalmitis of 0.04% with one case of presumed sterile endophthalmitis," Michael S. Ip, MD, said at Retina 2008, held in conjunction with Hawaiian Eye 2008. "We released these results because we feel there is a public health importance to realize that, with triamcinolone, you don't necessarily get a higher rate of endophthalmitis than you do with anti-VEGF [injections]."
Dr. Ip reported that there were 898 injections performed in the SCORE (Standard Care vs. Corticosteroid for Retinal Vein Occlusion) Study and 1,716 injections performed in the DRCR.net (Diabetic Retinopathy Clinical Research Network). Of those 2,614 injections, there was one confirmed case of endophthalmitis and one presumed case of sterile endophthalmitis.
In pooled data from seven other studies involving 3,248 patients treated with intravitreal injections of Kenalog (triamcinolone, Bristol-Meyers Squibb), Dr. Ip said there were 10 (0.3%) cases of endophthalmitis.
"The thought of this may be changing in terms of why this occurs. Previously, we've always agreed that it might be one of the excipients of the Kenalog formulation," he said. "But perhaps one of the new thoughts is that this may actually be due to a particle dispersion."
Unlike these other studies, the SCORE study uses a proprietary formula of triamcinolone prepared by Allergan, Dr. Ip said. He explained that this formula is sterile, free of endotoxins and potentially harmful excipients. It is a hyaluronate suspension not prone to crystal dispersion and comes in a pre-loaded syringe that allows for multiple dosing, he said. Dr. Ip said this formulation is not yet commercially available.
"It looks as if with this study and this formulation, it's comparable to anti-VEGF endophthalmitis rates," he said.
The VISION, ANCHOR and MARINA trials had endophthalmitis rates of 0.1%, less than 0.1% and 0.05%, respectively, Dr. Ip said.
"I would say at this point we're having a love-fest with anti-VEGF therapy. We go to meetings and that's all we hear," he said. "I'd like to remind you that just a few short years ago we certainly had a love-fest with intravitreal corticosteroids. You couldn't go to a meeting without hearing 20 talks on intravitreal corticosteroids."