SAR 1118 in Human Subjects Undergoing Pars Plana Vitrectomy

Diabetic Macular Edema (DME) Clinical Trial

Official title: A Phase 1b, Randomized, Uncontrolled, Single-masked, Safety, Tolerability, and Pharmacokinetic Study of Multiple Doses of Three Different Concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution in Human Subjects Undergoing Elective Pars Plana Vitrectomy (PPV)

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of SAR 1118 within the anterior and posterior chamber of the eye and plasma in subjects undergoing elective vitrectomy when treated with escalating concentrations of the study drug for approximately 1 week.

Clinical Trial Description

SAR 1118 is a potent and selective small molecule lymphocyte function antigen-1 (LFA-1) antagonist and may be therapeutically useful as a novel topical anti-inflammatory agent in a wide variety of ocular inflammatory conditions including diabetic retinopathy and diabetic macular edema. Recent evidence has demonstrated that topically delivered SAR 1118 ophthalmic solution can be detected in the aqueous, vitreous, and retina 4 to 12 hours after dosing at potentially therapeutic levels in animal models. However, the ability for the current sterile ophthalmic formulation of SAR 1118 to penetrate in sufficiently high therapeutic concentrations into the anterior and posterior chamber in humans is unknown. ;

Related Conditions & MeSH terms

• Diabetic Macular Edema (DME)
• Macular Edema
• Pars Plana Vitrectomy

• NCT number: NCT00936520
• Study type: Interventional
• Source: Johns Hopkins University
• Status: Terminated
• Phase: Phase 1
• Start date: August 2009
• Completion date: May 2010