Clinical trial NCT04499248: AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: Open-angle glaucoma
Ocular hypertension
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-08-05
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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).

Primary outcomes:
measure: Change from Baseline in Hour 0 Intraocular Pressure (IOP) in the Study Eye
timeFrame: Baseline to Month 36
measure: Number of participants experiencing treatment emergent adverse events
timeFrame: Baseline to Month 36
Secondary outcomes:
measure: Time to Rescue Treatment or Re-Treatment in the Study Eye
timeFrame: Baseline to Month 36
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Horizon Eye Specialists & Lasik Center - Sun City /ID# 252153
state: Arizona
city: Glendale
country: United States
facility: Global Research Management /ID# 241699
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute /ID# 241701
state: California
city: Irvine
country: United States
facility: Lakeside Vision Center /ID# 241698
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation /ID# 234528
state: California
city: Sacramento
country: United States
facility: Sacramento Eye Consultants /ID# 241697
state: California
city: Torrance
country: United States
facility: Premiere Practice Management LLC /ID# 235957
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates /ID# 241700
state: California
city: Danbury
country: United States
facility: Connecticut Eye Consultants P.C. /ID# 235862
state: Connecticut
city: Crystal River
country: United States
facility: Nature Coast Clinical Research - Crystal River /ID# 237781
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Ophthalmology - Jacksonville /ID# 243122
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute /ID# 235762
state: Florida
city: Tamarac
country: United States
facility: Logan Ophthalmic Research Inc. /ID# 252087
state: Florida
city: Roswell
country: United States
facility: Coastal Research Associates /ID# 234649
state: Georgia
city: Sandy Springs
country: United States
facility: Thomas Eye Group PC /ID# 266775
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago /ID# 253630
state: Illinois
city: Carmel
country: United States
facility: Midwest Medical Advisors Inc /ID# 235845
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University - Glick Eye Institute /ID# 235887
state: Indiana
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston /ID# 236535
state: Massachusetts
city: Fraser
country: United States
facility: Fraser Eye Care Center /ID# 267100
state: Michigan
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation at Pepose Vision Institute /ID# 267094
state: Missouri
city: Kansas City
country: United States
facility: Silverstein Eye Centers /ID# 266767
state: Missouri
city: Saint Louis
country: United States
facility: Tekwani Vision Center /ID# 235149
state: Missouri
city: Newark
country: United States
facility: Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 234365
state: New Jersey
city: South Orange
country: United States
facility: Northern New Jersey Eye Institute PA /ID# 241545
state: New Jersey
city: Asheville
country: United States
facility: Asheville Eye Associates /ID# 234963
state: North Carolina
city: Winston-Salem
country: United States
facility: Private Practice - Dr. James D. Branch /ID# 234560
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University /ID# 267590
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Eye Surgeons /ID# 252089
state: Oklahoma
city: Eugene
country: United States
facility: Drs Fine Hoffman & Sims LLC /ID# 235919
state: Oregon
city: Cranberry Township
country: United States
facility: Scott and Christie and Associates /ID# 252284
state: Pennsylvania
city: Memphis
country: United States
facility: Eye Specialty Group /ID# 252201
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Eye Institute /ID# 266915
state: Tennessee
city: Smyrna
country: United States
facility: Advancing Vision Research /ID# 236683
state: Tennessee
city: Austin
country: United States
facility: Keystone Research /ID# 266772
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center /ID# 272087
state: Texas
city: Saint George
country: United States
facility: St. George Eye Center /ID# 236200
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center /ID# 246455
state: Virginia
city: Roanoke
country: United States
facility: Vistar Eye Center /ID# 234811
state: Virginia
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital /ID# 238880
state: Kanagawa
city: Wako
country: Japan
facility: National Hospital Organization Saitama Hospital /ID# 266953
state: Saitama
city: Izumo-shi
country: Japan
facility: Shimane University Hospital /ID# 238641
state: Shimane
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital /ID# 238871
state: Tokyo
city: Tama-shi
country: Japan
facility: Nippon Medical School Tama Nagayama Hospital /ID# 273428
state: Tokyo
city: Chuo-shi
country: Japan
facility: University of Yamanashi Hospital /ID# 238642
state: Yamanashi
city: Fukuoka
country: Japan
facility: Hayashi eye hospital /ID# 267604
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: