ST266 Eyedrops for the Treatment of Persistent Corneal Epithelial Defects

October 24, 2022 updated by: Noveome Biotherapeutics, formerly Stemnion

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of ST266 Eye Drops in the Treatment of Persistent Corneal Epithelial Defects

The primary objective is to determine the efficacy of ST266 eye drops in healing persistent epithelial defects (PED). After 8 weeks of randomized, double-blind treatment, non-healers will enter into an additional 8-week open-label ST266 treatment period. All patients will be followed for 3-months post-treatment for monitoring of safety and maintenance of re-epithelialization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Trinity Research Group
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Huntington Beach, California, United States, 92647
        • Atlantis Eye Care
      • Los Angeles, California, United States, 90095
        • UCLA Stein Eye Institute
      • Palo Alto, California, United States, 94303
        • Stanford
      • Pasadena, California, United States, 91105
        • UCLA Doheny Eye Center
      • Pasadena, California, United States, 91107
        • California Eye Specialists Medical Group
    • Florida
      • Jacksonville, Florida, United States, 32259
        • Bowden Eye & Associates
      • Largo, Florida, United States, 33733
        • Shettle Eye Research
      • Miami, Florida, United States, 33143
        • Medeye Associates
      • Miami, Florida, United States, 33125
        • Millennium Clinical Research, INC
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Cincinnati Eye Institute
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Eye Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Mercy Clinic Eye Specialists- Ophthalmology
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • UNMC Truhlsen Eye Institute
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • UNC Kittner Eye Center
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
      • Columbus, Ohio, United States, 43212
        • OSU Wexner Medical Center
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Ophthalmic Partners, PC
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Eye Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77025
        • Houston Eye Associates
      • Houston, Texas, United States, 77030
        • Blanton Eye Institute/Houston Methodist Eye Associates
      • Hurst, Texas, United States, 76054
        • Texas Eye Research Center
      • San Antonio, Texas, United States, 78229
        • R and R Eye Research, LLC
    • Virginia
      • Lynchburg, Virginia, United States, 34502
        • Piedmont Eye Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • WVU Eye Institute
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • The Eye Centers of Racine and Kenosha
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and non-pregnant/non-breastfeeding female subjects aged 18 years and older.
  2. Subjects with a PED present for at least seven (7) days at the time of Screening.
  3. The defect must be at least 1.0 mm (longest linear measurement) at Screening and Baseline (Day 1) and must be measurable by slit lamp.
  4. In the Investigator's opinion, the defect is persistent i.e., the defect has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses.
  5. The original defect to the cornea must be the result of an injury, infection, disease, or surgery to the eye.

Exclusion Criteria:

  1. Diabetic cohort only: enrollment will be limited to include up to 50% of subjects with diabetes, as indicated by HbA1c level >6.5%. Subjects with a HbA1c level >6.5% after closure of the diabetic cohort will be excluded.
  2. Subjects currently being treated with cenegermin or other rhNGF in the study eye.
  3. Subjects currently using topical antibiotic eye drops in the study eye. Subjects on current antibiotic therapy must be willing to switch to study-provided moxifloxacin.
  4. Subjects currently taking topical steroids or corticosteroid-containing eye drops or ointment in the study eye. Subjects currently taking systemic corticosteroids with a dose of >10mg/day prednisone or equivalent.
  5. Subjects currently using topical antihistamine eye drops or vasoconstrictors in the study eye.
  6. Subjects currently using topical or local immunosuppressive agents (e.g., optic cyclosporine or lifitegrast) in the study eye.
  7. Subjects who require treatment with autologous serum eyedrops or amnion products in the study eye.
  8. Subjects who need to use contact lenses for refractive correction during the study.
  9. Subjects who require treatment with bandage contact lens or punctal plugs in the study eye that cannot be removed.
  10. Subjects currently taking antiviral medications for an active infection in the study eye. Subjects taking antiviral medications for prophylaxis may be enrolled in the study at the Investigator's discretion, provided that the subject remain on a stable dosing regimen throughout the duration of the study.
  11. History of ocular surgery (including laser or refractive surgery) in the study eye within 1 month prior to study screening or, in the opinion of the Investigator, there are persistent post-surgical complications that would impact the study data.
  12. Subjects with an uncontrolled lid or ocular infection in the study eye.
  13. History of alkali burns of the cornea.
  14. The circumference affected by limbal blood vessel ischemia is greater than 75 percent of the limbal circulation.
  15. Subjects with severe lid abnormalities contributory to the persistence of the PED such as inability to close the lids.
  16. Subjects who have a history of AIDS or HIV.
  17. Subjects who have participated in a clinical trial (including a previous study involving ST266) within 30 days prior to Day 1.
  18. Subjects who have more than one distinct PED in the study eye prior to screening visits. Subjects who develop PEDs after the screening visit will remain in the study; however, only the original study PED will be assessed.
  19. For subjects with bilateral PEDs, only the eye with the larger PED should be entered into the study. The non-study eye will receive standard of care treatment and be observed throughout the trial.
  20. Subjects with bullous keratopathy in the study eye.
  21. Subjects with corneal perforation or impending corneal perforation in the study eye.
  22. Subjects with uncontrolled glaucoma.
  23. Female subjects who are pregnant or breastfeeding. Female subjects who are neither postmenopausal for at least 1 year nor surgically sterile require a negative urine pregnancy test. All subjects must use an acceptable form of birth control during the study such as abstinence, barrier method, or hormonal contraceptive.
  24. Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Mooren's ulceration.
  25. Subjects with recurrent corneal erosion or corneal basement membrane dystrophy.
  26. Known hypersensitivity to study provided lubricating drops, antibiotic drops, and/or procedural medications such as fluorescein dye.
  27. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ST266.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ST266
Topical ocular application: one drop in the study eye four times a day for 8 weeks
Biological: ST266
Topical ocular application: one drop four times a day for eight weeks
Biological: Open-label ST266
Open label extension for non-healers after completion of double-blind treatment phase: topical ocular application of one drop four times a day for eight weeks
Placebo Comparator: Placebo
Topical ocular application: one drop in the study eye four times a day for 8 weeks
Biological: Open-label ST266
Open label extension for non-healers after completion of double-blind treatment phase: topical ocular application of one drop four times a day for eight weeks
Other: 0.67% Sodium Chloride Ophthalmic Solution
Topical ocular application: one drop four times a day for eight weeks
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Success
Time Frame: 8 weeks
Proportion of subjects with clinical success between ST266 and placebo arms, defined as complete re-epithelialization of the corneal epithelial defect by week 8 of treatment.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety of ST266
Time Frame: 7 months
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) in subjects treated with ST266 versus placebo
7 months
Time to re-epithelialization
Time Frame: 8 weeks
Time (in days) to first complete re-epithelization of PED in subjects treated with ST266 versus placebo.
8 weeks
Maintenance of re-epithelialization during treatment
Time Frame: 8 weeks
Time (in days) of re-epithelialization maintenance during treatment.
8 weeks
Maintenance of re-epithelialization post-treatment
Time Frame: 12 weeks
Maintenance of corneal re-epithelization at 2 weeks and up to 12 weeks after the end of treatment in subjects treated with ST266 versus placebo.
12 weeks
Change in BCVA from Baseline
Time Frame: 7 months
Mean change in Best Corrected Visual Acuity (BCVA) from Baseline over time and maintenance up to 12 weeks after the end of treatment in subjects treated with ST266 versus placebo.
7 months
Incidence of Rescue Therapy
Time Frame: 8 weeks
Incidence of need for rescue within 8 weeks in subjects treated with ST266 versus placebo.
8 weeks
Clinical Success in Open-Label Extension
Time Frame: 8 weeks
Proportion of subjects with complete re-epithelization of the corneal epithelial defect after 8 weeks of open label treatment based on the Independent Reading Center (IRC) image assessment.
8 weeks
Use of Lubricating Drops
Time Frame: 8 weeks
Mean usage of preservative-free lubricating drops used for comfort in subjects treated with ST266 versus placebo.
8 weeks
VAS Score
Time Frame: 8 weeks
Mean change in Visual Analog Scale (VAS) score from Baseline over time in subjects treated with ST266 versus placebo.
8 weeks
Size of Defect
Time Frame: 7 months
Size of epithelial defect
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Noveome Biotherapeutics, formerly Stemnion

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IQVIA Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ST266-PED-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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