SAR 1118 in Human Subjects Undergoing Pars Plana Vitrectomy

NCT00936520 | Terminated Phase 1

• 1 other identifier: NA_00029830
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetic Macular Edema; DME; Pars Plana Vitrectomy; Ocular Inflammation

Outcome Measures

Primary Outcomes (1)

• Primary outcome variable: frequency of ocular and non-ocular adverse events judged related to administration of SAR 1118 Ophthalmic Solution, or of inability to tolerate the medication.

  35 days

Secondary Outcomes (1)

• Secondary outcome variable: concentrations of SAR 1118 in aqueous and vitreous on the day of vitrectomy.

  day 9

Study Arms (3)

Dose 1

EXPERIMENTAL

SAR 1118 dose 0.1%

Drug: SAR 1118 0.1%

Dose 2

EXPERIMENTAL

SAR 1118 dose 1.0%

Drug: SAR 1118 1.0%

Dose 3

EXPERIMENTAL

SAR 1118 dose 5.0%

Drug: SAR 1118 5.0%

Interventions

SAR 1118 0.1% DRUG

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

Dose 1

SAR 1118 1.0% DRUG

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

Dose 2

SAR 1118 5.0% DRUG

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

Dose 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Human subjects meeting the following criteria will be enrolled:
• Age ≥18 years
• BCVA ≤20/40 in the study eye (BCVA measured at 4M ETDRS)
• Male or female
• Current non-smoker (last date of smoking should be at least 60 days before study enrollment)
• Surgically eligible to undergo elective PPV including, but not limited to, epiretinal membrane, vitreomacular traction, macular holes, or retinal detachment. The elective surgery must be able to be scheduled at least 21 days in advance to allow time for screening and for initiation of study drugs.
• Females must be non-pregnant, non-lactating, surgically sterile for at least 3 months, post-menopausal for at least 1 years with follicle stimulating hormone (FSH) greater than or equal to 40 mIU/mL, or willing to use an approved method of contraception from 35 days prior to first study drug administration. Approved methods of contraception include: a non-hormonal intrauterine device (IUD) with spermicide, a female condom with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, use of a condom with spermicide by sexual partner or sterile sexual partner.
• Willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures.
• Willing and able to comply with all study procedures including follow-up instructions

You may not qualify if:

• Individuals not eligible to participate in this study include those who meet any of the following criteria:
• Vitreous hemorrhage
• Active retinal detachment
• Autoimmune disease of the anterior segment or posterior chamber including chronic keratoconjunctivitis sicca, uveitis, iritis/scleritis, blepharitis of either eye
• Glaucoma requiring topical medications, infectious conjunctivitis, keratitis, or endophthalmitis of either eye
• Prior vitrectomy or intraocular lens placement, within 90 days of Day 0
• Previous intravitreal drug delivery administered in the study eye within the following time period of Day 0:
• Intravitreal steroid given ≤3 months
• Intravitreal vascular endothelial growth factor inhibitors given ≤2 months
• Previous participation in any studies of investigational drugs within 1 month preceding Day 0
• Any concurrent ophthalmic over-the-counter or topical ocular pharmaceutical within 30 days of Day 0 with the exception of saline tear lubricant.
• History of malignancy, renal insufficiency, or hepatic insufficiency
• Positive serum pregnancy test
• Use of any oral, implantable, or injectable contraceptive within 30 days or 5 half-lives of the contraceptive (whichever is longer) prior to first study drug administration; patients must refrain from these types of contraceptives during the treatment period and may resume the use of such contraceptives following the 1-week observation period.
• Any history of excessive alcohol (as judged by the Investigator) or illicit drug use/abuse

Sponsors & Collaborators

• Johns Hopkins University: lead
• SARcode Bioscience: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Study Officials

• Diana V Do, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

US (1)