Phase 2 trial underway for dexamethasone implant in patients with DME, RVO
The first patient has been treated in a phase 2 trial investigating IBE-814 IVT in patients with diabetic macular edema or macular edema due to retinal vein occlusion, according to a press release from Ripple Therapeutics.
IBE-814 IVT is designed to release a sustained low dose of dexamethasone from an intravitreal implant to the retina for about 6 months.
The multicenter, single-masked, dose-ranging RIPPLE-1 study will evaluate the safety and efficacy of the implant in two dosage regimens. Up to 50 eyes of 50 patients with DME or RVO in Australia and New Zealand will be enrolled and evaluated for 18 months. Primary endpoints include safety, macular edema and visual acuity, the release said.
“With the lower but sustained release dose of dexamethasone, I am hopeful that IBE-814 IVT will ultimately provide a much-needed treatment option,” Sanj Wickremasinghe, BSc, MBBS, FRCOphth, FRANZCO, principal investigator at the Centre for Eye Research of Australia, said in the release.