- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05066698
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
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- 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
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Alabama
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Dothan, Alabama, United States, 36301
- Trinity Research Group
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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California
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Huntington Beach, California, United States, 92647
- Atlantis Eye Care
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Los Angeles, California, United States, 90095
- UCLA Stein Eye Institute
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Palo Alto, California, United States, 94303
- Stanford
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Pasadena, California, United States, 91105
- UCLA Doheny Eye Center
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Pasadena, California, United States, 91107
- California Eye Specialists Medical Group
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Florida
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Jacksonville, Florida, United States, 32259
- Bowden Eye & Associates
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Largo, Florida, United States, 33733
- Shettle Eye Research
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Miami, Florida, United States, 33143
- MedEye Associates
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Miami, Florida, United States, 33125
- Millennium Clinical Research, INC
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Kentucky
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Edgewood, Kentucky, United States, 41017
- Cincinnati Eye Institute
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Eye Associates
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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Boston, Massachusetts, United States, 02114
- Massachusetts Eye and Ear
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Missouri
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Springfield, Missouri, United States, 65804
- Mercy Clinic Eye Specialists- Ophthalmology
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Nebraska
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Omaha, Nebraska, United States, 68105
- UNMC Truhlsen Eye Institute
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North Carolina
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Chapel Hill, North Carolina, United States, 27517
- UNC Kittner Eye Center
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Ohio
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Cincinnati, Ohio, United States, 45242
- Cincinnati Eye Institute
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Columbus, Ohio, United States, 43212
- OSU Wexner Medical Center
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, United States, 19004
- Ophthalmic Partners, PC
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt Eye Institute
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Houston, Texas, United States, 77025
- Houston Eye Associates
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Houston, Texas, United States, 77030
- Blanton Eye Institute/Houston Methodist Eye Associates
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Hurst, Texas, United States, 76054
- Texas Eye Research Center
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San Antonio, Texas, United States, 78229
- R and R Eye Research, LLC
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Virginia
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Lynchburg, Virginia, United States, 34502
- Piedmont Eye Center
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West Virginia
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Morgantown, West Virginia, United States, 26505
- WVU Eye Institute
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Wisconsin
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Kenosha, Wisconsin, United States, 53142
- The Eye Centers of Racine and Kenosha
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Madison, Wisconsin, United States, 53705
- University of Wisconsin
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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
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and non-pregnant/non-breastfeeding female subjects aged 18 years and older.
- Subjects with a PED present for at least seven (7) days at the time of Screening.
- 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.
- 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.
- The original defect to the cornea must be the result of an injury, infection, disease, or surgery to the eye.
Exclusion Criteria:
- 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.
- Subjects currently being treated with cenegermin or other rhNGF in the study eye.
- 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.
- 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.
- Subjects currently using topical antihistamine eye drops or vasoconstrictors in the study eye.
- Subjects currently using topical or local immunosuppressive agents (e.g., optic cyclosporine or lifitegrast) in the study eye.
- Subjects who require treatment with autologous serum eyedrops or amnion products in the study eye.
- Subjects who need to use contact lenses for refractive correction during the study.
- Subjects who require treatment with bandage contact lens or punctal plugs in the study eye that cannot be removed.
- 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.
- 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.
- Subjects with an uncontrolled lid or ocular infection in the study eye.
- History of alkali burns of the cornea.
- The circumference affected by limbal blood vessel ischemia is greater than 75 percent of the limbal circulation.
- Subjects with severe lid abnormalities contributory to the persistence of the PED such as inability to close the lids.
- Subjects who have a history of AIDS or HIV.
- Subjects who have participated in a clinical trial (including a previous study involving ST266) within 30 days prior to Day 1.
- 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.
- 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.
- Subjects with bullous keratopathy in the study eye.
- Subjects with corneal perforation or impending corneal perforation in the study eye.
- Subjects with uncontrolled glaucoma.
- 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.
- Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Mooren's ulceration.
- Subjects with recurrent corneal erosion or corneal basement membrane dystrophy.
- Known hypersensitivity to study provided lubricating drops, antibiotic drops, and/or procedural medications such as fluorescein dye.
- 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 |
Intervention / Treatment |
---|---|
Experimental: ST266
Topical ocular application: one drop in the study eye four times a day for 8 weeks
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Topical ocular application: one drop four times a day for eight weeks
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
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Placebo Comparator: Placebo
Topical ocular application: one drop in the study eye four times a day for 8 weeks
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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
Topical ocular application: one drop four times a day for eight weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Success
Time Frame: 8 weeks
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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.
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8 weeks
|
Secondary Outcome Measures
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
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7 months
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Time to re-epithelialization
Time Frame: 8 weeks
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Time (in days) to first complete re-epithelization of PED in subjects treated with ST266 versus placebo.
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8 weeks
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Maintenance of re-epithelialization during treatment
Time Frame: 8 weeks
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Time (in days) of re-epithelialization maintenance during treatment.
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8 weeks
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Maintenance of re-epithelialization post-treatment
Time Frame: 12 weeks
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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.
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12 weeks
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Change in BCVA from Baseline
Time Frame: 7 months
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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.
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7 months
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Incidence of Rescue Therapy
Time Frame: 8 weeks
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Incidence of need for rescue within 8 weeks in subjects treated with ST266 versus placebo.
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8 weeks
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Clinical Success in Open-Label Extension
Time Frame: 8 weeks
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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.
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8 weeks
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Use of Lubricating Drops
Time Frame: 8 weeks
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Mean usage of preservative-free lubricating drops used for comfort in subjects treated with ST266 versus placebo.
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8 weeks
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VAS Score
Time Frame: 8 weeks
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Mean change in Visual Analog Scale (VAS) score from Baseline over time in subjects treated with ST266 versus placebo.
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8 weeks
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Size of Defect
Time Frame: 7 months
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Size of epithelial defect
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7 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
April 27, 2022
Primary Completion (Actual)
September 7, 2022
Study Completion (Actual)
September 7, 2022
Study Registration Dates
First Submitted
September 23, 2021
First Submitted That Met QC Criteria
September 23, 2021
First Posted (Actual)
October 4, 2021
Study Record Updates
Last Update Posted (Actual)
October 25, 2022
Last Update Submitted That Met QC Criteria
October 24, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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