ST266 Eyedrops for the Treatment of Persistent Corneal Epithelial Defects

NCT05066698 | Terminated Phase 2 FDA Drug

• 1 other identifier: ST266-PED-202
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 31

Brief 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. All patients will be followed for 3-months post-treatment for monitoring of safety and maintenance of re-epithelialization.

Conditions

Persistent Corneal Epithelial Defect

Outcome Measures

Primary Outcomes (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.

  8 weeks

Secondary Outcomes (10)

• Safety of ST266

  7 months

• Time to re-epithelialization

  8 weeks

• Maintenance of re-epithelialization during treatment

  8 weeks

• Maintenance of re-epithelialization post-treatment

  12 weeks

• Change in BCVA from Baseline

  7 months

Study Arms (2)

ST266

EXPERIMENTAL

Topical ocular application: one drop in the study eye four times a day for 8 weeks

Biological: ST266; Biological: Open-label ST266

Placebo

PLACEBO COMPARATOR

Topical ocular application: one drop in the study eye four times a day for 8 weeks

Other: 0.67% Sodium Chloride Ophthalmic Solution; Biological: Open-label ST266

Interventions

ST266 BIOLOGICAL

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

ST266

0.67% Sodium Chloride Ophthalmic Solution OTHER

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

Also known as: Placebo

Placebo

Open-label ST266 BIOLOGICAL

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; ST266

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noveome Biotherapeutics, formerly Stemnion: lead
• IQVIA Biotech: collaborator

Study Sites (31)

Trinity Research Group

Dothan, Alabama, 36301, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Atlantis Eye Care

Huntington Beach, California, 92647, United States

Location

UCLA Stein Eye Institute

Los Angeles, California, 90095, United States

Location

Stanford

Palo Alto, California, 94303, United States

Location

UCLA Doheny Eye Center

Pasadena, California, 91105, United States

Location

California Eye Specialists Medical Group

Pasadena, California, 91107, United States

Location

Bowden Eye & Associates

Jacksonville, Florida, 32259, United States

Location

Shettle Eye Research

Largo, Florida, 33733, United States

Location

Millennium Clinical Research, Inc

Miami, Florida, 33125, United States

Location

MedEye Associates

Miami, Florida, 33143, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

University of Maryland Eye Associates

Baltimore, Maryland, 21201, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

Location

Mercy Clinic Eye Specialists- Ophthalmology

Springfield, Missouri, 65804, United States

Location

UNMC Truhlsen Eye Institute

Omaha, Nebraska, 68105, United States

Location

UNC Kittner Eye Center

Chapel Hill, North Carolina, 27517, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

OSU Wexner Medical Center

Columbus, Ohio, 43212, United States

Location

Ophthalmic Partners, PC

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Vanderbilt Eye Institute

Nashville, Tennessee, 37232, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Blanton Eye Institute/Houston Methodist Eye Associates

Houston, Texas, 77030, United States

Location

Texas Eye Research Center

Hurst, Texas, 76054, United States

Location

R and R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 34502, United States

Location

WVU Eye Institute

Morgantown, West Virginia, 26505, United States

Location

The Eye Centers of Racine and Kenosha

Kenosha, Wisconsin, 53142, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled trial with Open-Label Extension

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: April 27, 2022
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

US (31)