NCT03145025

Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant

An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Accepted

Summary

An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes Treated with a Fluocinolone Acetonide Intravitreal Implant

Detailed description

This is a prospective, multicenter, open-label, single arm, observational evaluation of the corneal ECD change from baseline for subjects having the Retisert FA drug delivery system (0.59 mg) surgically implanted in the ocular vitreous chamber of at least 1 previously unimplanted eye for at least 1 year.

Conditions

• Uveitis, Posterior

Interventions

Type	Name	Description
DEVICE	Retisert	Intravitreal Implant
DRUG	Fluocinolone Acetonide Intravitreal Implant	Intravitreal Implant

Timeline

• Start date: 2017-07-14
• Primary completion: 2018-09-10
• Completion: 2019-03-22
• First posted: 2017-05-09
• Last updated: 2019-06-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study