CompletedPhase 1

Study of ST266 Given by Intranasal Delivery in Glaucoma Suspect Subjects

United States9 participantsStarted 2019-10-23

Plain-language 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.

Who can participate

Age range

20 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. Gonioscopy open to at least scleral spur with normal iris configuration.
. Normal baseline neuro-cognitive testing.

Exclusion criteria

. 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:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: 18 months (entire duration of study)

Trial details

NCT IDNCT03901781

SponsorNoveome Biotherapeutics, formerly Stemnion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-20

View on ClinicalTrials.gov More Ocular Hypertension trials