Ireland
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Active, not recruiting Phase 1/2

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

NCT04499248 · tracked via the Priya Life Science Japan tracker
Sponsor
Phase
Phase 1/2
Started
2020-11-16
Last updated
2026-05-22

Condition(s) studied

Open-angle GlaucomaOcular Hypertension

Investigational drug(s) / intervention(s)

AGN-193408 SRLumiganSham AdministrationLumigan VehicleAGN-193408 SRSham AdministrationLumigan Vehicle

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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Change from Baseline in Hour 0 Intraocular Pressure (IOP) in the Study Eye — Baseline to Month 36
    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.
  • Number of participants experiencing treatment emergent adverse events — Baseline to Month 36

Trial sites (49)

FacilityCityRegionStatus
Horizon Eye Specialists & Lasik Center - Sun City /ID# 252153 Sun City Arizona
Global Research Management /ID# 241699 Glendale California
United Medical Research Institute /ID# 241701 Inglewood California
Lakeside Vision Center /ID# 241698 Irvine California
The Eye Research Foundation /ID# 234528 Newport Beach California
Sacramento Eye Consultants /ID# 241697 Sacramento California
Premiere Practice Management LLC /ID# 235957 Torrance California
Wolstan & Goldberg Eye Associates /ID# 241700 Torrance California
Connecticut Eye Consultants P.C. /ID# 235862 Danbury Connecticut
Brandon Eye Associates - Brandon /ID# 276600 Brandon Florida
Nature Coast Clinical Research - Crystal River /ID# 237781 Crystal River Florida
Advanced Research, LLC /ID# 276987 Deerfield Beach Florida
University of Florida Health Ophthalmology - Jacksonville /ID# 243122 Jacksonville Florida
East Florida Eye Institute /ID# 235762 Stuart Florida
Logan Ophthalmic Research Inc. /ID# 252087 Tamarac Florida
Coastal Research Associates /ID# 234649 Roswell Georgia
Thomas Eye Group PC /ID# 266775 Sandy Springs Georgia
University of Illinois Hospital and Health Sciences System /ID# 253630 Chicago Illinois
Midwest Medical Advisors Inc /ID# 235845 Carmel Indiana
Indiana University - Glick Eye Institute /ID# 235887 Indianapolis Indiana
Ophthalmic Consultants of Boston /ID# 236535 Boston Massachusetts
Fraser Eye Care Center /ID# 267100 Fraser Michigan
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 267094 Chesterfield Missouri
Silverstein Eye Centers /ID# 266767 Kansas City Missouri
Tekwani Vision Center /ID# 235149 St Louis Missouri
Nv Eye Surgery - Henderson /ID# 276925 Henderson Nevada
Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 234365 Newark New Jersey
Northern New Jersey Eye Institute /ID# 241545 South Orange New Jersey
Asheville Eye Associates /ID# 234963 Asheville North Carolina
Private Practice - Dr. James D. Branch /ID# 234560 Winston-Salem North Carolina
The Ohio State University /ID# 267590 Columbus Ohio
Oklahoma Eye Surgeons /ID# 252089 Oklahoma City Oklahoma
Drs Fine Hoffman & Sims LLC /ID# 235919 Eugene Oregon
Scott and Christie and Associates /ID# 252284 Cranberry Township Pennsylvania
Eye Specialty Group /ID# 252201 Memphis Tennessee
Vanderbilt Eye Institute /ID# 266915 Nashville Tennessee
Advancing Vision Research /ID# 236683 Smyrna Tennessee
Macro Trials (SMO/Network/Consortium) /ID# 266772 Austin Texas
San Antonio Eye Center /ID# 272087 San Antonio Texas
St. George Eye Center /ID# 236200 St. George Utah

+ 9 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04499248 on ClinicalTrials.gov ↗ ← All trials in Japan