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Open-angle GlaucomaPhase 1/2NCT04499248

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

A Phase 1/2 study testing AGN-193408 SR and Lumigan in people with Open-angle Glaucoma and Ocular Hypertension, run by AbbVie at 49 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Open-angle Glaucoma, Ocular Hypertension
What is being tested?
AGN-193408 SR and Lumigan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
49 sitesin 2 countries
Study dates
16 Nov 2020to Apr 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • 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).

Who cannot join

  • 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.
Show all 27Show fewer
  • 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).

Trial locations and contacts

49 sites in 2 countries.

49 sites in 2 countries

United States42 sites

  • Asheville Eye Associates /ID# 234963

    Asheville, North Carolina, 28803

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

    Austin, Texas, 78731

  • Ophthalmic Consultants of Boston /ID# 236535

    Boston, Massachusetts, 02129

  • Brandon Eye Associates - Brandon /ID# 276600

    Brandon, Florida, 33511

  • Midwest Medical Advisors Inc /ID# 235845

    Carmel, Indiana, 46290

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

    Chesterfield, Missouri, 63017

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

    Chicago, Illinois, 60607

  • The Ohio State University /ID# 267590

    Columbus, Ohio, 43210

  • Scott and Christie and Associates /ID# 252284

    Cranberry Township, Pennsylvania, 16066

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

    Crystal River, Florida, 34429

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

    Danbury, Connecticut, 06810

  • Advanced Research, LLC /ID# 276987

    Deerfield Beach, Florida, 33064-1346

  • Drs Fine Hoffman & Sims LLC /ID# 235919

    Eugene, Oregon, 97401

  • Fraser Eye Care Center /ID# 267100

    Fraser, Michigan, 48026

  • Global Research Management /ID# 241699

    Glendale, California, 91204-2500

  • Nv Eye Surgery - Henderson /ID# 276925

    Henderson, Nevada, 89052

  • Indiana University - Glick Eye Institute /ID# 235887

    Indianapolis, Indiana, 46202

  • United Medical Research Institute /ID# 241701

    Inglewood, California, 90301

  • Lakeside Vision Center /ID# 241698

    Irvine, California, 92604

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

    Jacksonville, Florida, 32209-6533

  • Silverstein Eye Centers /ID# 266767

    Kansas City, Missouri, 64133

  • Piedmont Eye Center /ID# 246455

    Lynchburg, Virginia, 24502

  • Eye Specialty Group /ID# 252201

    Memphis, Tennessee, 38120

  • Vanderbilt Eye Institute /ID# 266915

    Nashville, Tennessee, 37232-0025

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

    Newark, New Jersey, 07103-2425

  • The Eye Research Foundation /ID# 234528

    Newport Beach, California, 92663-3637

  • Oklahoma Eye Surgeons /ID# 252089

    Oklahoma City, Oklahoma, 73112

  • Vistar Eye Center /ID# 234811

    Roanoke, Virginia, 24011

  • Coastal Research Associates /ID# 234649

    Roswell, Georgia, 30076

  • Sacramento Eye Consultants /ID# 241697

    Sacramento, California, 95815

  • San Antonio Eye Center /ID# 272087

    San Antonio, Texas, 78215

  • Thomas Eye Group PC /ID# 266775

    Sandy Springs, Georgia, 30328

  • Advancing Vision Research /ID# 236683

    Smyrna, Tennessee, 37167

  • Northern New Jersey Eye Institute /ID# 241545

    South Orange, New Jersey, 07079

  • Tekwani Vision Center /ID# 235149

    St Louis, Missouri, 63128

  • St. George Eye Center /ID# 236200

    St. George, Utah, 84790

  • East Florida Eye Institute /ID# 235762

    Stuart, Florida, 34994

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

    Sun City, Arizona, 85351

  • Logan Ophthalmic Research Inc. /ID# 252087

    Tamarac, Florida, 33321

  • Premiere Practice Management LLC /ID# 235957

    Torrance, California, 90505

  • Wolstan & Goldberg Eye Associates /ID# 241700

    Torrance, California, 90505

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

    Winston-Salem, North Carolina, 27101

Other trials in United States

Japan7 sites

  • The University of Tokyo Hospital /ID# 238871

    Bunkyo-ku, Tokyo, 113-8655

  • University of Yamanashi Hospital /ID# 238642

    Chuo-shi, Yamanashi, 409-3898

  • Hayashi eye hospital /ID# 267604

    Fukuoka, 812-0011

  • Duplicate_Shimane University Hospital /ID# 238641

    Izumo-shi, Shimane, 693-8501

  • Kitasato University Hospital /ID# 238880

    Sagamihara-shi, Kanagawa, 252-0375

  • Nippon Medical School Tama Nagayama Hospital /ID# 273428

    Tama-shi, Tokyo, 206-8512

  • National Hospital Organization Saitama Hospital /ID# 266953

    Wako, Saitama, 351-0102

Other trials in Japan

About this study

Official title: A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

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

Being tested
AGN-193408 SR, Lumigan, Sham Administration, Lumigan Vehicle
Keywords
Open-angle glaucoma, Ocular hypertension
Medical subject headings
Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGN-193408 SRDrug

    An implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix. Implants are preloaded into an applicator to facilitate insertion of the implant into the anterior chamber of the study eye.

  • LumiganOther

    Also called Active Comparator

    Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost

  • Sham AdministrationOther

    Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.

  • Lumigan VehicleOther

    Also called Vehicle

    Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 2.

  • AGN-193408 SRDrug

    An implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix. Implants are preloaded into an applicator to facilitate insertion of the implant in the study eye.

  • Sham AdministrationOther

    Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.

  • Lumigan VehicleOther

    Also called Vehicle

    Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 3.

Study groups in NCT04499248
Study groupRoleWhat they receive
Cohort 1 -Dose AExperimentalSingle dose of AGN-193408 SR Dose A administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.
Receives: Drug: AGN-193408 SR; Other: Lumigan
Cohort 1 - Dose BExperimentalSingle dose of AGN-193408 SR Dose B administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.
Receives: Drug: AGN-193408 SR; Other: Lumigan
Cohort 2 - Dose AExperimentalAGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
Receives: Drug: AGN-193408 SR; Other: Lumigan; Other: Sham Administration; Other: Lumigan Vehicle
Cohort 2 - Dose BExperimentalAGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
Receives: Drug: AGN-193408 SR; Other: Lumigan; Other: Sham Administration; Other: Lumigan Vehicle
Cohort 3 - Dose AExperimentalAGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
Receives: Other: Lumigan; Drug: AGN-193408 SR; Other: Sham Administration; Other: Lumigan Vehicle
Cohort 3 - Dose BExperimentalAGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
Receives: Other: Lumigan; Drug: AGN-193408 SR; Other: Sham Administration; Other: Lumigan Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

    Measured: Baseline to Month 36

  2. Number of participants experiencing treatment emergent adverse events

    Measured: Baseline to Month 36

Secondary outcomes (1)

  1. Time to Rescue Treatment or Re-Treatment in the Study Eye

    Time to rescue treatment or the second treatment is defined as the time between the first treatment and the second treatment in the study eye.

    Measured: Baseline to Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2020
  2. Study start16 Nov 2020
  3. Primary completionApr 2029 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04499248
Sponsor's protocol ID
1833-201-407
Status last verified
May 2026
First submitted
31 Jul 2020
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AGN-193408 SR and Lumigan in people with Open-angle Glaucoma and Ocular Hypertension, run by AbbVie at 49 sites in 2 countries.

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 3 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Japan. 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 combined 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.

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?

This study is still under way. Results are not available in the source record yet.

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?

Change from Baseline in Hour 0 Intraocular Pressure (IOP) in the Study Eye (time frame: Baseline to Month 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04499248.

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 22 May 2026.

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