Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 10 for:    Noveome

ST266 Eye Drops for the Treatment of Persistent Corneal Epithelial Defects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03687632
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Noveome Biotherapeutics, formerly Stemnion

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

Condition or disease Intervention/treatment Phase
Persistent Corneal Epithelial Defect Biological: ST266 Phase 2

Detailed Description:

Efficacy:

The primary aim of the study is to evaluate the clinical response of ST266 treated subjects with persistent corneal epithelial defects after 28 days of therapy. The secondary endpoint is the response rate after 14 days of treatment. Failures are subjects that do not completely heal during 28 days of therapy. The longest measurement and the measurement perpendicular to that will be determined and the area calculated. The change in area and perimeter of epithelial defect from baseline at Day 15 (14 days of treatment) and Day 29 (28 days of treatment) will be calculated for each subject. The time to complete re-epithelialization is defined as the time from the start of therapy (Baseline Visit/Day 1) to the Day when no defect is observed. The number and percent of responders and failures will be summarized at each visit. Graphical representation of percent of responders and failures will be provided. The change in area and perimeter of epithelial defect from baseline through Day 15 (14 days of treatment) and Day 29 (28 days of treatment) will be summarized. Visualization of mean (Standard Deviation) of the change in area and perimeter will be provided at each time point. The time to complete re-epithelialization will be summarized and listed.

Safety:

Subject demographics, baseline characteristics and relevant medical history will be summarized and listed. Data for ST266 administration and concomitant therapies will be listed.

The number and percent of subjects with treatment emergent adverse events and ST266 related adverse events will be tabulated by system organ class and preferred terms.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a Phase 2, open label trial to determine if treatment with ST266 eye drops for 28 days heals the study eye.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open Label Trial of ST266 Eye Drops in the Treatment of Persistent Corneal Epithelial Defects
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Single arm - active
ST266 eye drops given to the study eye for 28 days (112 doses total will be administered).
Biological: ST266
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).




Primary Outcome Measures :
  1. Percent of subjects with complete healing of PED within 14 days of treatment starting [ Time Frame: 28 days ]
    Healing is defined as the complete re-epithelialization of the epithelial defect as determined by slit lamp examination with fluorescein staining.


Secondary Outcome Measures :
  1. Safety endpoint of the incidence of adverse and serious adverse events [ Time Frame: 28 days ]
    The secondary safety endpoint is the incidence of adverse and serious adverse events throughout the 28 days of treatment. For the safety evaluation, changes in visual acuity, IOP, and fluorescein staining will be considered as safety measures.

  2. Percent of subjects with complete healing [ Time Frame: 14 days ]
    Healing is defined as the complete re-epithelialization of the epithelial defect as determined by slit lamp examination with fluorescein staining.

  3. Time (in days) to complete re-epithelialization of the study eye [ Time Frame: This assessment will occur during clinic visits on days 4, 8, 11, 15, 22 and 29. ]
    Re-epithelialization of the epithelial defect as determined by slit lamp examination with fluorescein staining.

  4. Persistence of complete corneal re-epithelialization in the study eye [ Time Frame: The measurement will be made 7 days after end of treatment (at end of study visit). ]
    Corneal re-epithelialization in the study eye as determined by whether the healed epithelium remains intact after complete re-epithelialization is confirmed in the study eye, as determined by slit lamp examination with fluorescein staining.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 hard to heal and be a result of any injury, infection, disease or surgery to the eye.

Exclusion Criteria:

  • Subjects who are currently being treated with cenegermin.
  • Subject who requires 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, subject may be included in the clinical trial.
  • Subject who requires 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, 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.
  • Subject has had 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 with more than one distinct PED in the study eye.
  • Subjects with bullous keratopathy.
  • Subjects with corneal perforation or impending corneal perforation.
  • For subjects with bilateral PEDs, only the eye with the larger PED should be entered in to the study. The non-study eye will receive standard of care treatment and will be observed throughout the trial.
  • Female subjects who are pregnant or breastfeeding. Female subjects who are neither postmenopausal nor surgically sterile require a negative urine pregnancy test on Day 1 visit.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687632


Contacts
Layout table for location contacts
Contact: David L Steed, MD 412-402-9914 clinical@noveome.com

Locations
Layout table for location information
United States, Kentucky
Cincinnati Eye Institute Recruiting
Edgewood, Kentucky, United States, 41017
Principal Investigator: Edward J Holland, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Bennie Jeng, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: Pedram Hamrah, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: William Dupps, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Vatinee Y Bunya, MD         
Univesity of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Deepinder Dhaliwal, MD         
Sponsors and Collaborators
Noveome Biotherapeutics, formerly Stemnion

Layout table for additonal information
Responsible Party: Noveome Biotherapeutics, formerly Stemnion
ClinicalTrials.gov Identifier: NCT03687632     History of Changes
Other Study ID Numbers: ST266-PED-201
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Ophthalmic Solutions
Pharmaceutical Solutions