The Phase IIb clinical trial of I-vation TA (Merck & Co), an intravitreal injection incorporating triamcinolone acetonide (TA) for the treatment of diabetic macular oedema (DME), has been suspended.
The Phase IIb clinical trial of I-vation TA (Merck & Co), an intravitreal injection incorporating triamcinolone acetonide (TA) for the treatment of diabetic macular oedema (DME), has been suspended, according to an announcement made by Merck's research and licensing partner, SurModics, Inc.
The trial had been intended to evaluate the safety and efficacy of I-vation TA, an intravitreal implant that delivers TA on a sustained release basis. The minimally invasive implantation procedure is designed to reduce side effects and increase efficacy.
The study, whose design will now be re-evaluated, has been suspended because of the recent publication of study results advocating the superiority of laser treatments over intravitreal TA injections for the treatment of DME. The study did not address I-vation TA directly. Early results from the I-vation TA trial indicate a favourable tolerability profile for the compound.