Research Title: A Phase IIa Trial of TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO): A Double-masked, Randomized Trial to Evaluate Efficacy and Tolerability
Sponsor: Taiwan Liposome Company (TLC)
Principal Investigator: Robert Stoltz, M.D., PhD
Description: Subjects with macular edema will be screened and eligible subject will be enrolled to receive a single dose of the study drug (TLC399) with either of the three dose strengths by intravitreal (IVT) route. Each of the three groups will include approximately 22 subjects. The subjects will be followed for visual acuity, safety, tolerability and retinal thickness assessment after the single IVT injection of the study drug on Day 1.
Start Date: April 2017
Project Personnel: Leslie Marcus, CCRC; Caitlin Harrison, CCRC, COA; Stephanie Campbell, CRC, COA
Location(s): Marietta; 833 Campbell Hill Street, Suite 300, Marietta, GA 30060