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Persistent Corneal Epithelial DefectPhase 2NCT05066698

ST266 Eyedrops for the Treatment of Persistent Corneal Epithelial Defects

A Phase 2 study testing ST266, 0.67% Sodium Chloride Ophthalmic Solution and Open-label ST266 in people with Persistent Corneal Epithelial Defect, run by Noveome Biotherapeutics, formerly Stemnion at 31 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Persistent Corneal Epithelial Defect
What is being tested?
ST266, 0.67% Sodium Chloride Ophthalmic Solution and Open-label ST266
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
31 sitesUnited States
Study dates
27 Apr 2022to 7 Sep 2022
Phase
Phase 2
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

  • 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.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • Ophthalmic Partners, PC

    Bala-Cynwyd, Pennsylvania, 19004

  • University of Maryland Eye Associates

    Baltimore, Maryland, 21201

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02114

  • UNC Kittner Eye Center

    Chapel Hill, North Carolina, 27517

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • OSU Wexner Medical Center

    Columbus, Ohio, 43212

  • Trinity Research Group

    Dothan, Alabama, 36301

  • Cincinnati Eye Institute

    Edgewood, Kentucky, 41017

  • Houston Eye Associates

    Houston, Texas, 77025

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Blanton Eye Institute/Houston Methodist Eye Associates

    Houston, Texas, 77030

  • Atlantis Eye Care

    Huntington Beach, California, 92647

  • Texas Eye Research Center

    Hurst, Texas, 76054

  • Bowden Eye & Associates

    Jacksonville, Florida, 32259

  • The Eye Centers of Racine and Kenosha

    Kenosha, Wisconsin, 53142

  • Shettle Eye Research

    Largo, Florida, 33733

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • UCLA Stein Eye Institute

    Los Angeles, California, 90095

  • Piedmont Eye Center

    Lynchburg, Virginia, 34502

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Millennium Clinical Research, Inc

    Miami, Florida, 33125

  • MedEye Associates

    Miami, Florida, 33143

  • WVU Eye Institute

    Morgantown, West Virginia, 26505

  • Vanderbilt Eye Institute

    Nashville, Tennessee, 37232

  • UNMC Truhlsen Eye Institute

    Omaha, Nebraska, 68105

  • Stanford

    Palo Alto, California, 94303

  • UCLA Doheny Eye Center

    Pasadena, California, 91105

  • California Eye Specialists Medical Group

    Pasadena, California, 91107

  • R and R Eye Research, LLC

    San Antonio, Texas, 78229

  • Mercy Clinic Eye Specialists- Ophthalmology

    Springfield, Missouri, 65804

Other trials in United States

About this study

Official title: 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.

Being tested
ST266, 0.67% Sodium Chloride Ophthalmic Solution, Open-label ST266

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ST266Biological

    Topical ocular application: one drop four times a day for eight weeks

  • 0.67% Sodium Chloride Ophthalmic SolutionOther

    Also called Placebo

    Topical ocular application: one drop four times a day for eight weeks

  • Open-label ST266Biological

    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

Study groups in NCT05066698
Study groupRoleWhat they receive
ST266ExperimentalTopical ocular application: one drop in the study eye four times a day for 8 weeks
Receives: Biological: ST266; Biological: Open-label ST266
PlaceboPlacebo comparatorTopical ocular application: one drop in the study eye four times a day for 8 weeks
Receives: Other: 0.67% Sodium Chloride Ophthalmic Solution; Biological: Open-label ST266

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Success

    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.

    Measured: 8 weeks

Secondary outcomes (10)

  1. Safety of ST266

    Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) in subjects treated with ST266 versus placebo

    Measured: 7 months

  2. Time to re-epithelialization

    Time (in days) to first complete re-epithelization of PED in subjects treated with ST266 versus placebo.

    Measured: 8 weeks

  3. Maintenance of re-epithelialization during treatment

    Time (in days) of re-epithelialization maintenance during treatment.

    Measured: 8 weeks

  4. Maintenance of re-epithelialization post-treatment

    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.

    Measured: 12 weeks

  5. Change in BCVA from Baseline

    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.

    Measured: 7 months

  6. Incidence of Rescue Therapy

    Incidence of need for rescue within 8 weeks in subjects treated with ST266 versus placebo.

    Measured: 8 weeks

  7. Clinical Success in Open-Label Extension

    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.

    Measured: 8 weeks

  8. Use of Lubricating Drops

    Mean usage of preservative-free lubricating drops used for comfort in subjects treated with ST266 versus placebo.

    Measured: 8 weeks

  9. VAS Score

    Mean change in Visual Analog Scale (VAS) score from Baseline over time in subjects treated with ST266 versus placebo.

    Measured: 8 weeks

  10. Size of Defect

    Size of epithelial defect

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start27 Apr 2022
  3. Primary completion7 Sep 2022
  4. Study completion7 Sep 2022

Why it stopped: Sponsor undergoing financial hardships - no longer able to support trial; no safety concerns.

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-Blind, Placebo-Controlled trial with Open-Label Extension
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05066698
Sponsor's protocol ID
ST266-PED-202
Status last verified
Oct 2022
First submitted
23 Sep 2021
Last updated
25 Oct 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ST266, 0.67% Sodium Chloride Ophthalmic Solution and Open-label ST266 in people with Persistent Corneal Epithelial Defect, run by Noveome Biotherapeutics, formerly Stemnion at 31 sites 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 5 inclusion and 27 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 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: Sponsor undergoing financial hardships - no longer able to support trial; no safety concerns.). 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?

Clinical Success (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05066698.

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 25 Oct 2022.

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