AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension
NCT ID: NCT04499248
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
96 participants
INTERVENTIONAL
2020-11-16
2029-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1 -Dose A
Single 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.
AGN-193408 SR
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.
Lumigan
Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
Cohort 1 - Dose B
Single 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.
AGN-193408 SR
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.
Lumigan
Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
Cohort 2 - Dose A
AGN-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.
AGN-193408 SR
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.
Lumigan
Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
Sham Administration
Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.
Lumigan 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.
Cohort 2 - Dose B
AGN-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.
AGN-193408 SR
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.
Lumigan
Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
Sham Administration
Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.
Lumigan 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.
Cohort 3 - Dose A
AGN-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.
Lumigan
Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
AGN-193408 SR
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 Administration
Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.
Lumigan 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.
Cohort 3 - Dose B
AGN-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.
Lumigan
Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
AGN-193408 SR
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 Administration
Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.
Lumigan 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.
Interventions
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AGN-193408 SR
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.
Lumigan
Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
Sham Administration
Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.
Lumigan 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 SR
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 Administration
Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.
Lumigan 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Horizon Eye Specialists & Lasik Center - Sun City /ID# 252153
Sun City, Arizona, United States
Global Research Management /ID# 241699
Glendale, California, United States
United Medical Research Institute /ID# 241701
Inglewood, California, United States
Lakeside Vision Center /ID# 241698
Irvine, California, United States
The Eye Research Foundation /ID# 234528
Newport Beach, California, United States
Sacramento Eye Consultants /ID# 241697
Sacramento, California, United States
Premiere Practice Management LLC /ID# 235957
Torrance, California, United States
Wolstan & Goldberg Eye Associates /ID# 241700
Torrance, California, United States
Connecticut Eye Consultants P.C. /ID# 235862
Danbury, Connecticut, United States
Brandon Eye Associates - Brandon /ID# 276600
Brandon, Florida, United States
Nature Coast Clinical Research - Crystal River /ID# 237781
Crystal River, Florida, United States
University of Florida Health Ophthalmology - Jacksonville /ID# 243122
Jacksonville, Florida, United States
East Florida Eye Institute /ID# 235762
Stuart, Florida, United States
Logan Ophthalmic Research Inc. /ID# 252087
Tamarac, Florida, United States
Coastal Research Associates /ID# 234649
Roswell, Georgia, United States
Thomas Eye Group PC /ID# 266775
Sandy Springs, Georgia, United States
University of Illinois Hospital and Health Sciences System /ID# 253630
Chicago, Illinois, United States
Midwest Medical Advisors Inc /ID# 235845
Carmel, Indiana, United States
Indiana University - Glick Eye Institute /ID# 235887
Indianapolis, Indiana, United States
Ophthalmic Consultants of Boston /ID# 236535
Boston, Massachusetts, United States
Fraser Eye Care Center /ID# 267100
Fraser, Michigan, United States
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 267094
Chesterfield, Missouri, United States
Silverstein Eye Centers /ID# 266767
Kansas City, Missouri, United States
Tekwani Vision Center /ID# 235149
St Louis, Missouri, United States
Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 234365
Newark, New Jersey, United States
Northern New Jersey Eye Institute /ID# 241545
South Orange, New Jersey, United States
Asheville Eye Associates /ID# 234963
Asheville, North Carolina, United States
Private Practice - Dr. James D. Branch /ID# 234560
Winston-Salem, North Carolina, United States
The Ohio State University /ID# 267590
Columbus, Ohio, United States
Oklahoma Eye Surgeons /ID# 252089
Oklahoma City, Oklahoma, United States
Drs Fine Hoffman & Sims LLC /ID# 235919
Eugene, Oregon, United States
Scott and Christie and Associates /ID# 252284
Cranberry Township, Pennsylvania, United States
Eye Specialty Group /ID# 252201
Memphis, Tennessee, United States
Vanderbilt Eye Institute /ID# 266915
Nashville, Tennessee, United States
Advancing Vision Research /ID# 236683
Smyrna, Tennessee, United States
Macro Trials (SMO/Network/Consortium) /ID# 266772
Austin, Texas, United States
San Antonio Eye Center /ID# 272087
San Antonio, Texas, United States
St. George Eye Center /ID# 236200
St. George, Utah, United States
Piedmont Eye Center /ID# 246455
Lynchburg, Virginia, United States
Vistar Eye Center /ID# 234811
Roanoke, Virginia, United States
Kitasato University Hospital /ID# 238880
Sagamihara-shi, Kanagawa, Japan
National Hospital Organization Saitama Hospital /ID# 266953
Wako, Saitama, Japan
Duplicate_Shimane University Hospital /ID# 238641
Izumo-shi, Shimane, Japan
The University of Tokyo Hospital /ID# 238871
Bunkyo-ku, Tokyo, Japan
Nippon Medical School Tama Nagayama Hospital /ID# 273428
Tama-shi, Tokyo, Japan
University of Yamanashi Hospital /ID# 238642
Chuo-shi, Yamanashi, Japan
Hayashi eye hospital /ID# 267604
Fukuoka, , Japan
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
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Other Identifiers
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1833-201-407
Identifier Type: -
Identifier Source: org_study_id