ST266 Eyedrops for the Treatment of Persistent Corneal Epithelial Defects

Persistent Corneal Epithelial Defect Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05066698
• Other study ID #: ST266-PED-202
• Status: Terminated
• Phase: Phase 2
• Start date: April 27, 2022
• Est. completion date: September 7, 2022

Study information

• Verified date: October 2022
• Source: Noveome Biotherapeutics, formerly Stemnion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 7, 2022
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Persistent Corneal Epithelial Defect

Intervention

Biological:
• ST266
Topical ocular application: 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

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

Locations

Country	Name	City	State
United States	Ophthalmic Partners, PC	Bala-Cynwyd	Pennsylvania
United States	University of Maryland Eye Associates	Baltimore	Maryland
United States	Massachusetts Eye and Ear	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	UNC Kittner Eye Center	Chapel Hill	North Carolina
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	OSU Wexner Medical Center	Columbus	Ohio
United States	Trinity Research Group	Dothan	Alabama
United States	Cincinnati Eye Institute	Edgewood	Kentucky
United States	Baylor College of Medicine	Houston	Texas
United States	Blanton Eye Institute/Houston Methodist Eye Associates	Houston	Texas
United States	Houston Eye Associates	Houston	Texas
United States	Atlantis Eye Care	Huntington Beach	California
United States	Texas Eye Research Center	Hurst	Texas
United States	Bowden Eye & Associates	Jacksonville	Florida
United States	The Eye Centers of Racine and Kenosha	Kenosha	Wisconsin
United States	Shettle Eye Research	Largo	Florida
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	UCLA Stein Eye Institute	Los Angeles	California
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	University of Wisconsin	Madison	Wisconsin
United States	MedEye Associates	Miami	Florida
United States	Millennium Clinical Research, Inc	Miami	Florida
United States	WVU Eye Institute	Morgantown	West Virginia
United States	Vanderbilt Eye Institute	Nashville	Tennessee
United States	UNMC Truhlsen Eye Institute	Omaha	Nebraska
United States	Stanford	Palo Alto	California
United States	California Eye Specialists Medical Group	Pasadena	California
United States	UCLA Doheny Eye Center	Pasadena	California
United States	R and R Eye Research, LLC	San Antonio	Texas
United States	Mercy Clinic Eye Specialists- Ophthalmology	Springfield	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Noveome Biotherapeutics, formerly Stemnion	IQVIA Biotech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety of ST266	Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) in subjects treated with ST266 versus placebo	7 months
Secondary	Time to re-epithelialization	Time (in days) to first complete re-epithelization of PED in subjects treated with ST266 versus placebo.	8 weeks
Secondary	Maintenance of re-epithelialization during treatment	Time (in days) of re-epithelialization maintenance during treatment.	8 weeks
Secondary	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.	12 weeks
Secondary	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.	7 months
Secondary	Incidence of Rescue Therapy	Incidence of need for rescue within 8 weeks in subjects treated with ST266 versus placebo.	8 weeks
Secondary	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.	8 weeks
Secondary	Use of Lubricating Drops	Mean usage of preservative-free lubricating drops used for comfort in subjects treated with ST266 versus placebo.	8 weeks
Secondary	VAS Score	Mean change in Visual Analog Scale (VAS) score from Baseline over time in subjects treated with ST266 versus placebo.	8 weeks
Secondary	Size of Defect	Size of epithelial defect	7 months