Helical intravitreal triamcinolone acetonide implant: a 6-month surgical feasibility study in rabbits

To investigate the surgical feasibility and safety of a long-term intravitreal triamcinolone acetonide (TA) sustained delivery system.

Pigmented rabbits were implanted with sustained-release formulations containing 925 microg of TA within a non-biodegradable polymer coating: Dose A (n = 15) with a slow delivery rate of 1 to 2 microg/day and Dose B (n = 15) releasing 3 to 5 microg/day. Additionally, a control group (n = 10) using a device coated with polymer only was implanted. The devices were surgically implanted through a 30-gauge sclerotomy into the vitreous cavity. The animals were clinically observed for up to 6 months after the surgery with complete ophthalmologic examinations. Histologic evaluation of a subset of eyes was performed at the conclusion of the study.

Implants were successfully implanted in all 40 eyes. Ocular examinations revealed excellent implant tolerability. In all eyes, there was no significant postoperative inflammation at 1 week of follow-up. There was no increase in intraocular pressure during the follow-up period and histologic evaluation demonstrated no significant abnormalities. Minimal and localized vitreous hemorrhage was observed in 22.5% of implanted eyes and mostly cleared at 1 month after surgery. During the 6 months of follow up, localized lens opacities associated with physical implant contact developed in 66.6% of eyes.

The surgical procedure using the intravitreal TA sustained delivery device is feasible. Surgical complications were generally mild, with lens opacities attributable to unique anatomical features of the rabbit eye. Long-term follow-up and histology revealed excellent implant tolerability.