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Could an implant replace daily eye drops for glaucoma?

NCT ID NCT04499248

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an implant called AGN-193408 SR that is placed inside the eye to lower pressure in people with open-angle glaucoma or ocular hypertension. About 100 participants will receive the implant, and some will also get standard eye drops for comparison. The goal is to see if the implant is safe and effective at reducing eye pressure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AGN-193408 SR implant
What this could lead to
If successful, this implant could provide a longer-lasting way to lower eye pressure, reducing the need for daily eye drops.
What could go wrong
This is an early-phase trial with only 100 participants, so results may not apply to everyone. Risks include side effects from the implant procedure or the drug itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

100 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 the 4 months prior to treatment administration. * Any history of corneal graft, including partial grafts (eg, Descemet's Stripping Endothelial Keratoplasty \[DSEK\], Descemet's Membrane Endothelial Keratoplasty \[DMEK\]); or incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions in the study eye. * History of herpetic ocular diseases in either eye (including herpes simplex virus and varicella zoster virus). * Anticipated need for any incisional or laser ocular surgery in either eye during the study. * History of anatomically narrow angle resulting in evidence of angle changes or any history or closed angle glaucoma in the study eye. * History or evidence of a peripheral iridotomy/iridectomy in the inferior iris in the study eye. * Any history of trabeculectomy or other types of incisional glaucoma surgery, including a glaucoma seton or aqueous bypass stents in either eye, or minimally invasive glaucoma surgery (MIGS) type trabecular meshwork surgeries in the study eye. * Anticipated use of corticosteroids in either eye except for permitted interventions or systemically during the study, or historical use prior to Baseline within: * 3 years: intraocular fluocinolone acetonide * 6 months: intraocular corticosteroid(s) other than fluocinolone; any injectable periocular or sub-Tenon's/subconjunctival corticosteroid * 2 months: systemic (eg, oral, intramuscular, intravenous) or topical ocular corticosteroids * 2 weeks: dermal corticosteroids applied to skin of the eyelid(s), around the eye, or adnexa. * Anticipated use of other topical ocular medications in either eye except for permitted interventions. * The anticipated wearing of contact lenses in the study eye (Cohort 1) and both eyes (Cohorts 2 and 3) during the study that deviates from the following (contact lens wear is allowed during the study, but is to be temporarily discontinued before study visits, and before and after an Administration Day according to the following): * Use of soft lenses should be discontinued at least 3 days prior to Baseline, and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to Baseline * Use of soft lenses should be discontinued at least 3 days and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to a scheduled study visit or Administration Day visit * Use of contact lenses of any kind should be discontinued for 1 week following any AGN-193408 SR administration * Central corneal thickness of \< 480 or \> 620 micrometers in both eyes. * Visual field loss in the study eye that, in the opinion of the investigator, is functionally significant (eg, split fixation, field defect within the central 10 degrees that is visually significant or likely to cause central visual impairment upon progression) or shows evidence of progressive visual field loss within the year prior to Baseline. * Evidence of macular edema in either eye during screening or in participant's medical history. * At Screening, evidence of posterior synechia behind the iris inferiorly in the study eye that in the investigator's opinion may inhibit the ability to safely receive at least 1 AGN-193408 SR implant (Cohort 3 only).

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Conditions

The condition(s) this trial relates to.

ocular hypertension open-angle glaucoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ocular hypertension Open angle glaucoma

Contacts and locations

Locations

  • Advanced Research, LLC /ID# 276987

    Deerfield Beach, Florida, 33064-1346, United States

  • Advancing Vision Research /ID# 236683

    Smyrna, Tennessee, 37167, United States

  • Asheville Eye Associates /ID# 234963

    Asheville, North Carolina, 28803, United States

  • Brandon Eye Associates - Brandon /ID# 276600

    Brandon, Florida, 33511, United States

  • Coastal Research Associates /ID# 234649

    Roswell, Georgia, 30076, United States

  • Connecticut Eye Consultants P.C. /ID# 235862

    Danbury, Connecticut, 06810, United States

  • Drs Fine Hoffman & Sims LLC /ID# 235919

    Eugene, Oregon, 97401, United States

  • Duplicate_Shimane University Hospital /ID# 238641

    Izumo-shi, Shimane, 693-8501, Japan

  • East Florida Eye Institute /ID# 235762

    Stuart, Florida, 34994, United States

  • Eye Specialty Group /ID# 252201

    Memphis, Tennessee, 38120, United States

  • Fraser Eye Care Center /ID# 267100

    Fraser, Michigan, 48026, United States

  • Global Research Management /ID# 241699

    Glendale, California, 91204-2500, United States

  • Hayashi eye hospital /ID# 267604

    Fukuoka, 812-0011, Japan

  • Horizon Eye Specialists & Lasik Center - Sun City /ID# 252153

    Sun City, Arizona, 85351, United States

  • Indiana University - Glick Eye Institute /ID# 235887

    Indianapolis, Indiana, 46202, United States

  • Kitasato University Hospital /ID# 238880

    Sagamihara-shi, Kanagawa, 252-0375, Japan

  • Lakeside Vision Center /ID# 241698

    Irvine, California, 92604, United States

  • Logan Ophthalmic Research Inc. /ID# 252087

    Tamarac, Florida, 33321, United States

  • Macro Trials (SMO/Network/Consortium) /ID# 266772

    Austin, Texas, 78731, United States

  • Midwest Medical Advisors Inc /ID# 235845

    Carmel, Indiana, 46290, United States

  • Midwest Vision Research Foundation at Pepose Vision Institute /ID# 267094

    Chesterfield, Missouri, 63017, United States

  • National Hospital Organization Saitama Hospital /ID# 266953

    Wako, Saitama, 351-0102, Japan

  • Nature Coast Clinical Research - Crystal River /ID# 237781

    Crystal River, Florida, 34429, United States

  • Nippon Medical School Tama Nagayama Hospital /ID# 273428

    Tama-shi, Tokyo, 206-8512, Japan

  • Northern New Jersey Eye Institute /ID# 241545

    South Orange, New Jersey, 07079, United States

  • Nv Eye Surgery - Henderson /ID# 276925

    Henderson, Nevada, 89052, United States

  • Oklahoma Eye Surgeons /ID# 252089

    Oklahoma City, Oklahoma, 73112, United States

  • Ophthalmic Consultants of Boston /ID# 236535

    Boston, Massachusetts, 02129, United States

  • Piedmont Eye Center /ID# 246455

    Lynchburg, Virginia, 24502, United States

  • Premiere Practice Management LLC /ID# 235957

    Torrance, California, 90505, United States

  • Private Practice - Dr. James D. Branch /ID# 234560

    Winston-Salem, North Carolina, 27101, United States

  • Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 234365

    Newark, New Jersey, 07103-2425, United States

  • Sacramento Eye Consultants /ID# 241697

    Sacramento, California, 95815, United States

  • San Antonio Eye Center /ID# 272087

    San Antonio, Texas, 78215, United States

  • Scott and Christie and Associates /ID# 252284

    Cranberry Township, Pennsylvania, 16066, United States

  • Silverstein Eye Centers /ID# 266767

    Kansas City, Missouri, 64133, United States

  • St. George Eye Center /ID# 236200

    St. George, Utah, 84790, United States

  • Tekwani Vision Center /ID# 235149

    St Louis, Missouri, 63128, United States

  • The Eye Research Foundation /ID# 234528

    Newport Beach, California, 92663-3637, United States

  • The Ohio State University /ID# 267590

    Columbus, Ohio, 43210, United States

  • The University of Tokyo Hospital /ID# 238871

    Bunkyo-ku, Tokyo, 113-8655, Japan

  • Thomas Eye Group PC /ID# 266775

    Sandy Springs, Georgia, 30328, United States

  • United Medical Research Institute /ID# 241701

    Inglewood, California, 90301, United States

  • University of Florida Health Ophthalmology - Jacksonville /ID# 243122

    Jacksonville, Florida, 32209-6533, United States

  • University of Illinois Hospital and Health Sciences System /ID# 253630

    Chicago, Illinois, 60607, United States

  • University of Yamanashi Hospital /ID# 238642

    Chuo-shi, Yamanashi, 409-3898, Japan

  • Vanderbilt Eye Institute /ID# 266915

    Nashville, Tennessee, 37232-0025, United States

  • Vistar Eye Center /ID# 234811

    Roanoke, Virginia, 24011, United States

  • Wolstan & Goldberg Eye Associates /ID# 241700

    Torrance, California, 90505, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.