Diabetic Macular Edema (DME)Phase 1NCT00936520
SAR 1118 in Human Subjects Undergoing Pars Plana Vitrectomy
A Phase 1 study testing SAR 1118 0.1%, SAR 1118 1.0% and SAR 1118 5.0% in people with Diabetic Macular Edema (DME) and Pars Plana Vitrectomy, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME), Pars Plana Vitrectomy
- What is being tested?
- SAR 1118 0.1%, SAR 1118 1.0% and SAR 1118 5.0%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to May 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
- Consumption of any alcohol or any illicit drugs within one week of first study drug administration
- Use of any tobacco or nicotine-containing products within 2 months prior to first study drug administration
- Any laboratory abnormality considered clinically significant by the Investigators
- Subjects with a hemoglobin < 12.0 g/dL
- Any clinically significant acute or chronic medical condition that would preclude participation in a clinical study
- Any history of autoimmune disease, immunodeficiency disorder, positive HIV, acute hepatitis A (IgM positive), or hepatitis B, or C, or organ or bone marrow transplant
- Participation in an ongoing investigational drug or medical device study
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Being tested
- SAR 1118 0.1%, SAR 1118 1.0%, SAR 1118 5.0%
- Keywords
- Diabetic Macular Edema, DME, Pars Plana Vitrectomy, Ocular Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
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
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | SAR 1118 dose 0.1% Receives: Drug: SAR 1118 0.1% |
| Dose 2 | Experimental | SAR 1118 dose 1.0% Receives: Drug: SAR 1118 1.0% |
| Dose 3 | Experimental | SAR 1118 dose 5.0% Receives: Drug: SAR 1118 5.0% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 35 days
Secondary outcomes (1)
Secondary outcome variable: concentrations of SAR 1118 in aqueous and vitreous on the day of vitrectomy.
Measured: day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Preliminary analysis showed little or no bioactivity.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- SARcode Bioscience
- Responsible party
- Sponsor
- Investigators
- Diana V Do, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936520
- Sponsor's protocol ID
- NA_00029830
- Status last verified
- May 2017
- First submitted
- 9 Jul 2009
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00936520
- Acronym / sponsor ID
- NA_00029830
- Keywords
- Diabetic Macular Edema, DME, Pars Plana Vitrectomy, Ocular Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary analysis showed little or no bioactivity.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- SARcode Bioscience
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: SAR 1118 0.1%SAR 1118 dose 0.1% |
| Dose 2 | Experimental | Drug: SAR 1118 1.0%SAR 1118 dose 1.0% |
| Dose 3 | Experimental | Drug: SAR 1118 5.0%SAR 1118 dose 5.0% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Human subjects meeting the following criteria will be enrolled:
Key exclusion criteria (22 listed)
- Individuals not eligible to participate in this study include those who meet any of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dose 1 |
| 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 | Dose 2 |
| 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 | Drug | Dose 3 |
Primary outcome
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.
Time frame: 35 days
1 secondary outcome
Secondary outcome variable: concentrations of SAR 1118 in aqueous and vitreous on the day of vitrectomy.
Time frame: day 9
Results and safety
The study was stopped early (reason given: Preliminary analysis showed little or no bioactivity.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
Related trials for Diabetic Macular Edema (DME)
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
Diabetic Retinopathy, Macular Edema
RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
Diabetic Retinopathy, Macular Edema
Active, not recruitingPhase 3
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana V Do, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR 1118 0.1%, SAR 1118 1.0% and SAR 1118 5.0% in people with Diabetic Macular Edema (DME) and Pars Plana Vitrectomy, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Preliminary analysis showed little or no bioactivity.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.