Persistent Corneal Epithelial DefectPhase 2NCT03687632
ST266 Eye Drops for the Treatment of Persistent Corneal Epithelial Defects
A Phase 2 study testing ST266 in people with Persistent Corneal Epithelial Defect, run by Noveome Biotherapeutics, formerly Stemnion at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Corneal Epithelial Defect
- What is being tested?
- ST266
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Jun 2019to 25 Aug 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Maryland
Baltimore, Maryland, 21201
Tufts Medical Center
Boston, Massachusetts, 02111
Cleveland Clinic
Cleveland, Ohio, 44195
Cincinnati Eye Institute
Edgewood, Kentucky, 41017
Price Vision Group
Indianapolis, Indiana, 46260
University of West Virginia
Morgantown, West Virginia, 26506
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Univesity of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Phase 2 Open Label Trial of ST266 Eye Drops in the Treatment of Persistent Corneal Epithelial Defects
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.
Read the detailed description
Efficacy:
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. Failures are subjects that do not completely heal during 28 days of therapy. The epithelial defect can be of any size as long as it is measurable by slit lamp. 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 through 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.
- Conditions
- Persistent Corneal Epithelial Defect
- Being tested
- ST266
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST266Biological
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).
| Study group | Role | What they receive |
|---|---|---|
| Single arm - active | Experimental | ST266 eye drops given to the study eye for 28 days (112 doses total will be administered). Receives: Biological: ST266 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (4)
Safety endpoint of the incidence of adverse and serious adverse events
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.
Measured: 28 days
Percent of subjects with complete healing within 14 days of starting treatment
Healing is defined as the complete re-epithelialization of the epithelial defect as determined by slit lamp examination with fluorescein staining.
Measured: 14 days
Time (in days) to complete re-epithelialization of the study eye
Re-epithelialization of the epithelial defect as determined by slit lamp examination with fluorescein staining.
Measured: 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
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.
Measured: The measurement will be made 7 days after end of treatment (at end of study visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start10 Jun 2019
- Primary completion18 Aug 2020
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Corneal Epithelial DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noveome Biotherapeutics, formerly Stemnion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687632
- Sponsor's protocol ID
- ST266-PED-201
- Status last verified
- Aug 2021
- First submitted
- 24 Sep 2018
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open Label Trial of ST266 Eye Drops in the Treatment of Persistent Corneal Epithelial Defects
- ClinicalTrials.gov ID
- NCT03687632
- Acronym / sponsor ID
- ST266-PED-201
- Conditions
- Persistent Corneal Epithelial Defect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Noveome Biotherapeutics, formerly StemnionIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Efficacy:
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. Failures are subjects that do not completely heal during 28 days of therapy. The epithelial defect can be of any size as long as it is measurable by slit lamp. 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 through 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single arm - active | Experimental | Biological: ST266ST266 eye drops given to the study eye for 28 days (112 doses total will be administered). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST2661X ST266 applied in a dose of one drop (30-50 µL) in the study eye for 28 days (112 doses total will be administered). | Biological | Single arm - active |
Primary outcome
Proportion of subjects with complete healing of PED during 28 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.
4 secondary outcomes
Safety endpoint of the incidence of adverse and serious adverse events
Time frame: 28 days
Percent of subjects with complete healing within 14 days of starting treatment
Time frame: 14 days
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Persistent Corneal Epithelial Defect
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of TP-06 for PCED
Persistent Corneal Epithelial Defect
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
Recruiting
Autologous Platelet-rich Plasma in the Treatment of Persistent Epithelial Defects
Persistent Epithelial Defect
RecruitingPhase 4
Comparison of Topical Insulin and Amniotic Membrane Transplant for Persistent Corneal Epithelial Defects
Persistent Corneal Epithelial Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ST266 in people with Persistent Corneal Epithelial Defect, run by Noveome Biotherapeutics, formerly Stemnion at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with complete healing of PED during 28 days of treatment starting (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.