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SAR 1118 in Human Subjects Undergoing Pars Plana Vitrectomy

NCT00936520 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-05-10

No results posted yet for this study

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.

Conditions

  • Diabetic Macular Edema (DME)
  • Pars Plana Vitrectomy

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Diana V Do, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00936520 on ClinicalTrials.gov