ST266 Eye Drops for the Treatment of Persistent Corneal Epithelial Defects

NCT03687632 | Completed Phase 2 FDA Drug

• 1 other identifier: ST266-PED-201
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 8

Brief Summary

The primary aim of the study is to evaluate the clinical response of ST266 treated subjects with persistent corneal epithelial defects during 28 days of therapy. The secondary endpoint is the response rate within 14 days of treatment.

Conditions

Persistent Corneal Epithelial Defect

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with complete healing of PED during 28 days of treatment starting

  Healing is defined as the complete re-epithelialization of the epithelial defect as determined by slit lamp examination with fluorescein staining.

  28 days

Secondary Outcomes (4)

• Safety endpoint of the incidence of adverse and serious adverse events

  28 days

• Percent of subjects with complete healing within 14 days of starting treatment

  14 days

• Time (in days) to complete re-epithelialization of the study eye

  This assessment will occur during clinic visits on days 4, 8, 11, 15, 22 and 29.

• Persistence of complete corneal re-epithelialization in the study eye

  The measurement will be made 7 days after end of treatment (at end of study visit).

Study Arms (1)

Single arm - active

EXPERIMENTAL

ST266 eye drops given to the study eye for 28 days (112 doses total will be administered).

Biological: ST266

Interventions

ST266 BIOLOGICAL

1X ST266 applied in a dose of one drop (30-50 µL) in the study eye for 28 days (112 doses total will be administered).

Single arm - active

Eligibility Criteria

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

You may qualify if:

• Male and female subjects aged 18 years and over.
• Subjects with a PED present for at least seven (7) days.
• The defect may be of any size 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 any injury, infection, disease or surgery to the eye.

You may not qualify if:

• Subjects currently being treated with cenegermin.
• Subjects who require treatment with autologous serum eyedrops throughout the duration of the trial. If, in the opinion of the investigator, autologous serum eyedrop treatment can be safely stopped, the subject may be included in the clinical trial.
• Subjects who require treatment with other amnion products throughout the duration of the trial. If, in the opinion of the investigator, the amniotic product treatment can be safely stopped, the subject may be included in the clinical trial.
• Subject who requires treatment with amniotic membrane throughout the duration of the trial. If the amniotic membrane can be safely stopped, the subject may be included in the clinical trial. Note: The amniotic membrane must be removed at least one (1) day prior to the baseline visit.
• Subjects who require treatment with bandage contact lens that cannot be removed at least 24 hours prior to screening. If the bandage contact lens can be safely removed, the subject may be included in the clinical trial.
• Subject with an uncontrolled lid or ocular infection.
• History of alkali burns of the cornea.
• The circumference affected by limbal blood vessel ischemia is greater than 75 percent of the circumference.
• Subjects with severe lid abnormalities contributory to the persistence of the PED such as the inability to close the lids.
• Subjects who have a history of AIDS or HIV.
• Treatment with systemic corticosteroids (equivalent to \>10 mg/day of prednisone) or immunosuppressive (including Plaquenil) or chemotherapeutic agents within 7 days prior to Day 1, or likely to receive one of these therapies during study participation.
• Subjects who have participated in a clinical trial 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.
• Subjects with bullous keratopathy.
• Subjects with corneal perforation or impending corneal perforation.

Sponsors & Collaborators

• Noveome Biotherapeutics, formerly Stemnion: lead

Study Sites (8)

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Univesity of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of West Virginia

Morgantown, West Virginia, 26506, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 2, open label trial to determine if treatment with ST266 eye drops for 28 days heals the study eye.

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 27, 2018
• Study Start: June 10, 2019
• Primary Completion: August 18, 2020
• Study Completion: August 25, 2020
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)