Ocular HypertensionPhase 1NCT03901781
Study of ST266 Given by Intranasal Delivery in Glaucoma Suspect Subjects
A Phase 1 study testing ST266 via Intranasal Delivery in people with Ocular Hypertension, run by Noveome Biotherapeutics, formerly Stemnion at 1 site in United States.
Trial summary
The primary objective of this trial is to assess the safety of ST266 given by non-invasive intranasal trans-cribriform delivery to glaucoma suspect subjects with ocular hypertension, optic nerve cupping, or family history of glaucoma. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Ocular Hypertension
- What is being tested?
- ST266 via Intranasal Delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2019to 20 May 2022
- Phase
- Phase 1
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act) document.
- Male or Female, Ages 20-75 years.
- Must be clinically followed as a glaucoma suspect without evidence of glaucomatous damage.
- Must have one of the following: 1) IOP ≤ 28 mmHg and at least one (1) IOP measurement > 21 mmHg, or 2) physiologic cupping of the optic nerve, or 3) a family history of glaucoma.
- Two (2) normal visual fields (VF) both Swedish Interactive Threshold Algorithm - Short-wavelength Automated Perimetry (SITA-SWAP) and 24-2 VF prior to subject enrollment at the Baseline Visit.
- Two (2) normal Ocular Coherence Tomography (OCT) (of macula and nerve fiber layer) prior to subject enrollment at the Baseline Visit.
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- Gonioscopy open to at least scleral spur with normal iris configuration.
- Normal baseline neuro-cognitive testing.
- Normal baseline Magnetic Resonance Imaging (MRI), including expected age-related changes, performed with and without contrast.
- Cohort Three group only: Baseline Lumbar Puncture within normal limits.
Who cannot join
- Females of Child Bearing Potential (FOCBP) who are pregnant or lactating or who will not abstain from sexual activity for 14 days prior to Visit 1, and willing to remain so through 30 days following completion of the subject's first menstrual cycle following the End of Treatment (EOT) Visit. Alternatively, a WOCBP who will not remain abstinent must have been using one of the following acceptable methods of birth control for the times specified:
- IUD in place for at least three (3) months prior to Visit 1 until completion of the subject's first menstrual cycle following the EOT Visit.
- Barrier method (condom or diaphragm) with spermicide for at least three (3) months prior to Visit 1 through completion of the subject's first menstrual cycle following the EOT Visit.
- Stable hormonal contraceptive for at least three (3) months prior to Visit 1 through completion of the subject's first menstrual cycle following the EOT Visit. NOTE: For Depo-Provera injection contraceptives, the statement regarding first menstrual cycle following administration of the study product is not applicable as females receiving this form of contraception will not have menses.
- In a monogamous relationship with a surgically sterilized (i.e., vasectomized) partner at least six (6) months prior to Visit 1.
- Have undergone one of the following sterilization procedures at least six (6) months prior to Visit 1: Bilateral tubal ligation, Hysterectomy, Hysterectomy with unilateral or bilateral oophorectomy, Bilateral oophorectomy.
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- Unwillingness to submit a urine pregnancy test at screening if of childbearing potential.
- Male subjects who refuse to use one of the following birth control methods:
- Abstinence from the time of consent and through the duration of their participation in the protocol
- Barrier method (condom or diaphragm) with spermicide from time of consent through the duration of their participation in the protocol
- Surgical sterilization (vasectomy) at least 6 months prior to consent.
- IOP greater than 29 mmHg in either eye.
- Patients with high risk factors of ocular hypertension, such as thin central corneas, as identified by the Principal Investigator who may benefit from earlier treatment will be excluded.
- Evidence of Angle closure.
- Recent laser or incisional glaucoma surgery.
- Subjects who are currently taking glaucoma medications. Subject who can safely stop taking these medications during washout period (4-6 weeks) may be considered.
- Intranasal polyp or any head and/or neck neoplasm.
- History of or evidence on physical examination including endoscopy of sinus or nasal pathology, nasal passage obstruction, chronic sinus infections, or severe seasonal allergies.
- Currently using medications given intranasally.
- Subject is taking any anticoagulant medication such as heparin, low molecular weight heparin, Coumadin, or antiplatelet agents including low dose aspirin.
- History of stroke or Trans-Ischemic Attack (TIA) within the past five (5) years.
- Neuro-cognitively impaired as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
- Subjects who have participated in an investigational product trial within the past 30 days.
- Subjects who refuse any part of the protocol assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Dose-escalating Phase 1 Open-label Safety Study of ST266 Given by Non-invasive Intranasal Trans-cribriform Delivery in Glaucoma Suspect Subjects Without Evidence of Glaucomatous Damage.
The primary objective of this trial is to assess the safety of ST266 given by non-invasive intranasal trans-cribriform delivery to glaucoma suspect subjects with ocular hypertension, optic nerve cupping, or family history of glaucoma.
Read the detailed description
This clinical trial is a dose escalating design in three (3) cohorts. In the first cohort, subjects will be treated with ST266 delivered using a non-invasive trans-cribriform intranasal delivery device daily for 14 days, in alternating single nostrils. If there are no SAEs and no pattern of concern in the AE's, the Investigator may proceed to the second cohort. In Cohort Two, subjects will be administered ST266 to each nostril daily for 14 days. As with the first cohort, if there are no safety concerns, the investigator may move on to the third cohort. In Cohort Three, subjects will be administered ST266 to each nostril daily for 28 days. All subjects will be followed for 12 months after the last dose of study drug. ST266 will be administered by a health care professional trained to deliver ST266 intranasally. No efficacy data will be collected.
- Conditions
- Ocular Hypertension
- Being tested
- ST266 via Intranasal Delivery
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST266 via Intranasal DeliveryCombination product
ST266 administered by non-invasive trans-cribriform intranasal delivery using the SipNose intranasal device.
| Study group | Role | What they receive |
|---|---|---|
| Cohort One | Experimental | Three (3) subjects, ST266 200 µL administered by trans-cribriform intranasal device once a day for 14 days using alternating sides (nostrils) with a follow-up visit at seven (7) days following End of Treatment (EOT), a follow-up call at one (1) month, and follow-up visits at three (3) months, six (6) months and 12 months following EOT. Receives: Combination Product: ST266 via Intranasal Delivery |
| Cohort Two | Experimental | Three (3) subjects, ST266 400 µL administered by trans-cribriform intranasal device bilaterally (200 µL/nostril) once a day for 14 days with a follow-up visit at seven (7) days following EOT, a follow-up call at one (1) month, and follow-up visits at three (3) months, six (6) months and 12 months following EOT. Receives: Combination Product: ST266 via Intranasal Delivery |
| Cohort Three | Experimental | Three (3) subjects, 400 µL ST266 administered by trans-cribriform intranasal device bilaterally (200 µL/nostril) once a day for 28 days with a follow-up visit at seven (7) days following EOT, a follow-up call at one (1) month, and follow-up visits at three (3) months, six (6) months and 12 months following EOT. Receives: Combination Product: ST266 via Intranasal Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety will be determined by comparing the results of the screening tests at baseline and again at the end of the treatment period through the end of study. Adverse events (AEs) and Serious Adverse Events (SAEs) will be recorded. The primary safety variable is the incidence of subjects with any adverse event during the entire study.
Measured: 18 months (entire duration of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start23 Oct 2019
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This clinical trial is a dose escalating design in three (3) cohorts of three (3) subjects per Cohort. In the first cohort, subjects will be administered ST266, delivered intranasally, at a dose of two hundred microliters (200 µL) daily for 14 days, in alternating single nostrils. After 14 daily treatments there is a seven (7)-day follow-up period. If there are no SAEs and no pattern of concern in the AE's, the Investigator may proceed to the second cohort of three (3) subjects. In Cohort Two, three (3) subjects will be administered 200 µL to each nostril daily (400 µL total per day) for 14 days. There will be a seven (7)-day follow-up. Like Cohort One, if there are no safety concerns, the investigator may move on to the third cohort of three (3) subjects. In Cohort Three, three (3) subjects will be administered 200 µL to each nostril daily (400 µL total per day) for 28 days.
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT03901781
- Sponsor's protocol ID
- ST266-IOPHTN-101
- Status last verified
- Aug 2022
- First submitted
- 2 Apr 2019
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalating Phase 1 Open-label Safety Study of ST266 Given by Non-invasive Intranasal Trans-cribriform Delivery in Glaucoma Suspect Subjects Without Evidence of Glaucomatous Damage.
- ClinicalTrials.gov ID
- NCT03901781
- Acronym / sponsor ID
- ST266-IOPHTN-101
- Conditions
- Ocular Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Noveome Biotherapeutics, formerly StemnionIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 3 Apr 2019 (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 objective of this trial is to assess the safety of ST266 given by non-invasive intranasal trans-cribriform delivery to glaucoma suspect subjects with ocular hypertension, optic nerve cupping, or family history of glaucoma.
Detailed description
This clinical trial is a dose escalating design in three (3) cohorts. In the first cohort, subjects will be treated with ST266 delivered using a non-invasive trans-cribriform intranasal delivery device daily for 14 days, in alternating single nostrils. If there are no SAEs and no pattern of concern in the AE's, the Investigator may proceed to the second cohort. In Cohort Two, subjects will be administered ST266 to each nostril daily for 14 days. As with the first cohort, if there are no safety concerns, the investigator may move on to the third cohort. In Cohort Three, subjects will be administered ST266 to each nostril daily for 28 days. All subjects will be followed for 12 months after the last dose of study drug. ST266 will be administered by a health care professional trained to deliver ST266 intranasally. No efficacy data will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This clinical trial is a dose escalating design in three (3) cohorts of three (3) subjects per Cohort. In the first cohort, subjects will be administered ST266, delivered intranasally, at a dose of two hundred microliters (200 µL) daily for 14 days, in alternating single nostrils. After 14 daily treatments there is a seven (7)-day follow-up period. If there are no SAEs and no pattern of concern in the AE's, the Investigator may proceed to the second cohort of three (3) subjects. In Cohort Two, three (3) subjects will be administered 200 µL to each nostril daily (400 µL total per day) for 14 days. There will be a seven (7)-day follow-up. Like Cohort One, if there are no safety concerns, the investigator may move on to the third cohort of three (3) subjects. In Cohort Three, three (3) subjects will be administered 200 µL to each nostril daily (400 µL total per day) for 28 days.
| Arm | Type | Receives |
|---|---|---|
| Cohort One | Experimental | Combination Product: ST266 via Intranasal DeliveryThree (3) subjects, ST266 200 µL administered by trans-cribriform intranasal device once a day for 14 days using alternating sides (nostrils) with a follow-up visit at seven (7) days following End of Treatment (EOT), a follow-up call at one (1) month, and follow-up visits at three (3) months, six (6) months and 12 months following EOT. |
| Cohort Two | Experimental | Combination Product: ST266 via Intranasal DeliveryThree (3) subjects, ST266 400 µL administered by trans-cribriform intranasal device bilaterally (200 µL/nostril) once a day for 14 days with a follow-up visit at seven (7) days following EOT, a follow-up call at one (1) month, and follow-up visits at three (3) months, six (6) months and 12 months following EOT. |
| Cohort Three | Experimental | Combination Product: ST266 via Intranasal DeliveryThree (3) subjects, 400 µL ST266 administered by trans-cribriform intranasal device bilaterally (200 µL/nostril) once a day for 28 days with a follow-up visit at seven (7) days following EOT, a follow-up call at one (1) month, and follow-up visits at three (3) months, six (6) months and 12 months following EOT. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act) document.
- Male or Female, Ages 20-75 years.
- Must be clinically followed as a glaucoma suspect without evidence of glaucomatous damage.
- Must have one of the following: 1) IOP ≤ 28 mmHg and at least one (1) IOP measurement > 21 mmHg, or 2) physiologic cupping of the optic nerve, or 3) a family history of glaucoma.
- Two (2) normal visual fields (VF) both Swedish Interactive Threshold Algorithm - Short-wavelength Automated Perimetry (SITA-SWAP) and 24-2 VF prior to subject enrollment at the Baseline Visit.
Key exclusion criteria (24 listed)
- Females of Child Bearing Potential (FOCBP) who are pregnant or lactating or who will not abstain from sexual activity for 14 days prior to Visit 1, and willing to remain so through 30 days following completion of the subject's first menstrual cycle following the End of Treatment (EOT) Visit. Alternatively, a WOCBP who will not remain abstinent must have been using one of the following acceptable methods of birth control for the times specified:
- Unwillingness to submit a urine pregnancy test at screening if of childbearing potential.
- Male subjects who refuse to use one of the following birth control methods:
- IOP greater than 29 mmHg in either eye.
- Patients with high risk factors of ocular hypertension, such as thin central corneas, as identified by the Principal Investigator who may benefit from earlier treatment will be excluded.
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 |
|---|---|---|
| ST266 via Intranasal DeliveryST266 administered by non-invasive trans-cribriform intranasal delivery using the SipNose intranasal device. | Combination product | Cohort One, Cohort Three, Cohort Two |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 18 months (entire duration of study)
Safety will be determined by comparing the results of the screening tests at baseline and again at the end of the treatment period through the end of study. Adverse events (AEs) and Serious Adverse Events (SAEs) will be recorded. The primary safety variable is the incidence of subjects with any adverse event during the entire study.
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 23 Aug 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ST266 via Intranasal Delivery in people with Ocular Hypertension, run by Noveome Biotherapeutics, formerly Stemnion at 1 site 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 10 inclusion and 24 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 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 18 months (entire duration of study)). 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 23 Aug 2022.