To investigate side effects seen with this formulation and to search for evidence of effectiveness after a single intravitreal injection of IBI-20089 in eyes with cystoid macular edema (CME) secondary to retinal vein occlusion.
Prospective phase 1 clinical trial
10 patients with chronic CME due to retinal vein occlusion
Patients received a single intravitreal injection of IBI-20089 using a sequential dose escalation schedule. Each cohort consisted of five patients who received the intravitreal injection of the sustained liquid drug delivery system containing either 6.9 mg (25 ul) triamcinolone acetonide (TA) (Cohort 1) or 13.8 mg (50 ul) TA (Cohort 2). At each study visit, best corrected visual acuity testing, slit lamp biomicroscopy, intraocular pressure (IOP) measurement, dilated ophthalmoscopy, fundus photography and optical coherence tomography (OCT) were performed. Patients also underwent laboratory testing and physical examinations to monitor for any systemic adverse events.
Main Outcome measures
OCT central subfield thickness, ocular and systemic adverse events
In Cohort 1, mean baseline OCT central subfield thickness (CST) was 477 microns (μ) and decreased to 369 μ at day 1 (p< 0.06), 387 μ at day 30 (p= 0.18) and 251 μ at day 360 (p=0.46). In Cohort 2, mean baseline OCT CST was 518 μ, and decreased to 404 μ at day 1 (p=0.134), 289 μ at day 30 (p=0.003), 207 μ at day180 (p=0.004) and 278 μ at day 360 (p=0.009). Related adverse events included elevation of IOP in three patients; two due to neovascular glaucoma (not related to study drug) and one which required a glaucoma tube shunt.
A single intravitreal injection of IBI-20089 resulted in a controlled and sustained delivery of a TA. Side effects included elevated IOP in three eyes, two of which had neovascular glaucoma.