Clinical trial NCT05066698: ST266 Eyedrops for the Treatment of Persistent Corneal Epithelial Defects
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Persistent Corneal Epithelial Defect
Lead sponsor: Noveome Biotherapeutics, formerly Stemnion
Sponsor class: INDUSTRY
Collaborators: name: IQVIA Biotech
First posted: 2021-10-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled trial with Open-Label Extension
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Success
timeFrame: 8 weeks
Secondary outcomes:
measure: Safety of ST266
timeFrame: 7 months
measure: Time to re-epithelialization
timeFrame: 8 weeks
measure: Maintenance of re-epithelialization during treatment
timeFrame: 8 weeks
measure: Maintenance of re-epithelialization post-treatment
timeFrame: 12 weeks
measure: Change in BCVA from Baseline
timeFrame: 7 months
measure: Incidence of Rescue Therapy
timeFrame: 8 weeks
measure: Clinical Success in Open-Label Extension
timeFrame: 8 weeks
measure: Use of Lubricating Drops
timeFrame: 8 weeks
measure: VAS Score
timeFrame: 8 weeks
measure: Size of Defect
timeFrame: 7 months
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Trinity Research Group
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Huntington Beach
country: United States
facility: Atlantis Eye Care
state: California
city: Los Angeles
country: United States
facility: UCLA Stein Eye Institute
state: California
city: Palo Alto
country: United States
facility: Stanford
state: California
city: Pasadena
country: United States
facility: UCLA Doheny Eye Center
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group
state: California
city: Jacksonville
country: United States
facility: Bowden Eye & Associates
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research
state: Florida
city: Miami
country: United States
facility: Millennium Clinical Research, Inc
state: Florida
city: Miami
country: United States
facility: MedEye Associates
state: Florida
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Eye Associates
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
city: Springfield
country: United States
facility: Mercy Clinic Eye Specialists- Ophthalmology
state: Missouri
city: Omaha
country: United States
facility: UNMC Truhlsen Eye Institute
state: Nebraska
city: Chapel Hill
country: United States
facility: UNC Kittner Eye Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Columbus
country: United States
facility: OSU Wexner Medical Center
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Ophthalmic Partners, PC
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Blanton Eye Institute/Houston Methodist Eye Associates
state: Texas
city: Hurst
country: United States
facility: Texas Eye Research Center
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC
state: Texas
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Morgantown
country: United States
facility: WVU Eye Institute
state: West Virginia
city: Kenosha
country: United States
facility: The Eye Centers of Racine and Kenosha
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References: