Active — Not RecruitingPhase 1/2

AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension

United States, Japan100 participantsStarted 2020-11-16

Plain-language summary

This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (Cohort 2) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension

Who can participate

Age range

18 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: * Participant is willing to withhold his/her IOP (Intraocular Pressure) treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk. * Diagnosis of either OAG \[open-angle glaucoma\] (ie, \[POAG\], pseudoexfoliation glaucoma,pigmentary glaucoma) or OHT (ocular hypertension) in both eyes. * Must be pseudophakic (at least 4 months postcataract surgery prior to treatment administration \[Cycle 1 Day 1 Administration visit\]) (Cohort 3 only). Exclusion Criteria: * Known allergy or sensitivity to any study medication or its components, any component of the delivery vehicle, procedure-related materials, or diagnostic agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine). * Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study within 2 months prior to the Baseline visit through the final study visit. * History of intracameral implant in the study eye (eg, Bimatoprost SR, OTX-TIC, ENV515 Travoprost XR). * History of laser trabeculoplasty within 6 months prior to screening in the study eye. * History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc.) in the study eye. * History or evidence of complicated cataract/lens surgery, as stated in the protocol. * Intraocular surgery (including cataract surgery) in the study eye within …

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

Change from Baseline in Hour 0 Intraocular Pressure (IOP) in the Study Eye

Timeframe: Baseline to Month 36

Number of participants experiencing treatment emergent adverse events

Timeframe: Baseline to Month 36

Trial details

NCT IDNCT04499248

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-04

View on ClinicalTrials.gov More Open-angle Glaucoma trials

Who can participate

Age range

18 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.