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AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension
NCT04499248 · AbbVie
In plain English
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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
About this study
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 criteria
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).
Study design
Enrollment target: 96 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2020-11-16
Estimated completion: 2029-02
Last updated: 2026-03-23
Interventions
Drug: AGN-193408 SROther: LumiganOther: Sham AdministrationOther: Lumigan VehicleDrug: AGN-193408 SROther: Sham AdministrationOther: Lumigan Vehicle
Primary outcomes
- • Change from Baseline in Hour 0 Intraocular Pressure (IOP) in the Study Eye (Baseline to Month 36)
- • Number of participants experiencing treatment emergent adverse events (Baseline to Month 36)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (49)
Horizon Eye Specialists & Lasik Center - Sun City /ID# 252153Recruiting
Sun City, Arizona, United States
Global Research Management /ID# 241699Recruiting
Glendale, California, United States
United Medical Research Institute /ID# 241701Completed
Inglewood, California, United States
Lakeside Vision Center /ID# 241698Recruiting
Irvine, California, United States
The Eye Research Foundation /ID# 234528Recruiting
Newport Beach, California, United States
Sacramento Eye Consultants /ID# 241697Recruiting
Sacramento, California, United States
Premiere Practice Management LLC /ID# 235957Completed
Torrance, California, United States
Wolstan & Goldberg Eye Associates /ID# 241700Recruiting
Torrance, California, United States
Connecticut Eye Consultants P.C. /ID# 235862Recruiting
Danbury, Connecticut, United States
Brandon Eye Associates - Brandon /ID# 276600Recruiting
Brandon, Florida, United States
Nature Coast Clinical Research - Crystal River /ID# 237781Recruiting
Crystal River, Florida, United States
Advanced Research, LLC /ID# 276987Recruiting
Deerfield Beach, Florida, United States
University of Florida Health Ophthalmology - Jacksonville /ID# 243122Completed
Jacksonville, Florida, United States
East Florida Eye Institute /ID# 235762Recruiting
Stuart, Florida, United States
Logan Ophthalmic Research Inc. /ID# 252087Recruiting
Tamarac, Florida, United States
Coastal Research Associates /ID# 234649Recruiting
Roswell, Georgia, United States
Thomas Eye Group PC /ID# 266775Completed
Sandy Springs, Georgia, United States
University of Illinois Hospital and Health Sciences System /ID# 253630Recruiting
Chicago, Illinois, United States
Midwest Medical Advisors Inc /ID# 235845Completed
Carmel, Indiana, United States
Indiana University - Glick Eye Institute /ID# 235887Completed
Indianapolis, Indiana, United States
Ophthalmic Consultants of Boston /ID# 236535Recruiting
Boston, Massachusetts, United States
Fraser Eye Care Center /ID# 267100Recruiting
Fraser, Michigan, United States
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 267094Recruiting
Chesterfield, Missouri, United States
Silverstein Eye Centers /ID# 266767Recruiting
Kansas City, Missouri, United States
Tekwani Vision Center /ID# 235149Completed
St Louis, Missouri, United States
Nv Eye Surgery - Henderson /ID# 276925Recruiting
Henderson, Nevada, United States
Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 234365Completed
Newark, New Jersey, United States
Northern New Jersey Eye Institute /ID# 241545Recruiting
South Orange, New Jersey, United States
Asheville Eye Associates /ID# 234963Completed
Asheville, North Carolina, United States
Private Practice - Dr. James D. Branch /ID# 234560Recruiting
Winston-Salem, North Carolina, United States
The Ohio State University /ID# 267590Recruiting
Columbus, Ohio, United States
Oklahoma Eye Surgeons /ID# 252089Recruiting
Oklahoma City, Oklahoma, United States
Drs Fine Hoffman & Sims LLC /ID# 235919Completed
Eugene, Oregon, United States
Scott and Christie and Associates /ID# 252284Completed
Cranberry Township, Pennsylvania, United States
Eye Specialty Group /ID# 252201Recruiting
Memphis, Tennessee, United States
Vanderbilt Eye Institute /ID# 266915Recruiting
Nashville, Tennessee, United States
Advancing Vision Research /ID# 236683Recruiting
Smyrna, Tennessee, United States
Macro Trials (SMO/Network/Consortium) /ID# 266772Recruiting
Austin, Texas, United States
San Antonio Eye Center /ID# 272087Recruiting
San Antonio, Texas, United States
St. George Eye Center /ID# 236200Completed
St. George, Utah, United States
Piedmont Eye Center /ID# 246455Recruiting
Lynchburg, Virginia, United States
Vistar Eye Center /ID# 234811Completed
Roanoke, Virginia, United States
Kitasato University Hospital /ID# 238880Completed
Sagamihara-shi, Kanagawa, Japan
National Hospital Organization Saitama Hospital /ID# 266953Recruiting
Wako, Saitama, Japan
Duplicate_Shimane University Hospital /ID# 238641Completed
Izumo-shi, Shimane, Japan
The University of Tokyo Hospital /ID# 238871Recruiting
Bunkyo-ku, Tokyo, Japan
Nippon Medical School Tama Nagayama Hospital /ID# 273428Recruiting
Tama-shi, Tokyo, Japan
University of Yamanashi Hospital /ID# 238642Recruiting
Chuo-shi, Yamanashi, Japan
Hayashi eye hospital /ID# 267604Recruiting
Fukuoka, Japan