NCT06429306

Study of Dexycu in Treating Intraocular Inflammation

A Phase 3,Prospective, Randomized, Double-masked, Placebo-controlled, Parallel Study to Evaluate the Efficacy, PK and Safety of 9% Dexamethasone Intraocular Injection for the Treatment of Inflammation Associatedwith Cataract Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Ocumension Therapeutics (Shanghai) Co., Ltd · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, prospective, randomised, double-masked, placebo-controlled, parallel-design, multicenter study of the efficacy, safety and pharmacokinetics of 9% dexamethasone intraocular injection for the treatment of inflammation associated with cataract surgery.

Detailed description

This is a prospective, randomized, double-blindmasked, placebo-controlled, parallel- design, multicenter study of subjects over 40 years undergoing cataract surgery. Subjects meet the inclusion criteria and do not meet any exclusion criteria are randomiszed to the dexamethasone implant group or placebo group at a ratio of 2:1. Subjects received a single does injection in the study eye immediately after the completion of cataract surgery. The investigational drug comes with a special injection device and injection guide. All subjects will be administered to the study eye with quinolone topical antibiotic eye drops or their equivalent 3 days before and 7 days after surgery.

Conditions

• Inflammation
• Cataract

Interventions

Type	Name	Description
DRUG	Dexycu	5ul dexamethasone, concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone
DRUG	Placebo	Acetyl triethyl citrate

Timeline

• Start date: 2022-08-22
• Primary completion: 2023-11-24
• Completion: 2024-04-09
• First posted: 2024-05-24
• Last updated: 2024-08-26

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study