NCT00936520

SAR 1118 in Human Subjects Undergoing Pars Plana Vitrectomy

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetic Macular Edema (DME)
• Pars Plana Vitrectomy

Interventions

Type	Name	Description
DRUG	SAR 1118 0.1%	Daily eye drops (twice daily, \~50 microliter \[uL\] each drop) approximately 10 to 12 hours apart; morning and in the evening just prior to bedtime) to the study eye only for 8 consecutive days
DRUG	SAR 1118 1.0%	Daily eye drops (twice daily, \~50 uL each drop) approximately 10 to 12 hours apart; morning and in the evening just prior to bedtime) to the study eye only for 8 consecutive days
DRUG	SAR 1118 5.0%	Daily eye drops (twice daily, \~50 uL each drop) approximately 10 to 12 hours apart; morning and in the evening just prior to bedtime) to the study eye only for 8 consecutive days

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-07-10
• Last updated: 2017-05-10

Locations

1 site across 1 country: United States