A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Who is this study for? Patients with open-angle glaucoma or ocular hypertension
What treatments are being studied? AGN-193408 SR+Lumigan
Status: Recruiting
Location: See all (46) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
United States
Arizona
Horizon Eye Specialists & Lasik Center - Sun City /ID# 252153
RECRUITING
Sun City
California
Global Research Management /ID# 241699
RECRUITING
Glendale
United Medical Research Institute /ID# 241701
COMPLETED
Inglewood
Lakeside Vision Center /ID# 241698
RECRUITING
Irvine
The Eye Research Foundation /ID# 234528
RECRUITING
Newport Beach
Sacramento Eye Consultants /ID# 241697
RECRUITING
Sacramento
Premiere Practice Management LLC /ID# 235957
COMPLETED
Torrance
Wolstan & Goldberg Eye Associates /ID# 241700
RECRUITING
Torrance
Connecticut
Connecticut Eye Consultants P.C. /ID# 235862
RECRUITING
Danbury
Florida
Nature Coast Clinical Research - Crystal River /ID# 237781
RECRUITING
Crystal River
University of Florida Health Ophthalmology - Jacksonville /ID# 243122
COMPLETED
Jacksonville
East Florida Eye Institute /ID# 235762
RECRUITING
Stuart
Logan Ophthalmic Research Inc. /ID# 252087
RECRUITING
Tamarac
Georgia
Coastal Research Associates /ID# 234649
RECRUITING
Roswell
Thomas Eye Group PC /ID# 266775
RECRUITING
Sandy Springs
Illinois
University of Illinois Hospital and Health Sciences System /ID# 253630
RECRUITING
Chicago
Indiana
Midwest Medical Advisors Inc /ID# 235845
COMPLETED
Carmel
Indiana University - Glick Eye Institute /ID# 235887
COMPLETED
Indianapolis
Massachusetts
Ophthalmic Consultants of Boston /ID# 236535
RECRUITING
Boston
Michigan
Fraser Eye Care Center /ID# 267100
RECRUITING
Fraser
Missouri
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 267094
RECRUITING
Chesterfield
Silverstein Eye Centers /ID# 266767
RECRUITING
Kansas City
Tekwani Vision Center /ID# 235149
COMPLETED
St Louis
North Carolina
Asheville Eye Associates /ID# 234963
COMPLETED
Asheville
Private Practice - Dr. James D. Branch /ID# 234560
RECRUITING
Winston-salem
New Jersey
Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 234365
COMPLETED
Newark
Northern New Jersey Eye Institute /ID# 241545
RECRUITING
South Orange
Ohio
The Ohio State University /ID# 267590
RECRUITING
Columbus
Oklahoma
Oklahoma Eye Surgeons /ID# 252089
RECRUITING
Oklahoma City
Oregon
Drs Fine Hoffman & Sims LLC /ID# 235919
COMPLETED
Eugene
Pennsylvania
Scott and Christie and Associates /ID# 252284
COMPLETED
Cranberry Township
Tennessee
Eye Specialty Group /ID# 252201
RECRUITING
Memphis
Vanderbilt Eye Institute /ID# 266915
RECRUITING
Nashville
Advancing Vision Research /ID# 236683
RECRUITING
Smyrna
Texas
Macro Trials (SMO/Network/Consortium) /ID# 266772
RECRUITING
Austin
San Antonio Eye Center /ID# 272087
RECRUITING
San Antonio
Utah
St. George Eye Center /ID# 236200
COMPLETED
St. George
Virginia
Piedmont Eye Center /ID# 246455
RECRUITING
Lynchburg
Vistar Eye Center /ID# 234811
COMPLETED
Roanoke
Other Locations
Japan
The University of Tokyo Hospital /ID# 238871
RECRUITING
Bunkyo-ku
University of Yamanashi Hospital /ID# 238642
RECRUITING
Chuo-shi
Hayashi eye hospital /ID# 267604
RECRUITING
Fukuoka
Duplicate_Shimane University Hospital /ID# 238641
COMPLETED
Izumo-shi
Kitasato University Hospital /ID# 238880
COMPLETED
Sagamihara-shi
Nippon Medical School Tama Nagayama Hospital /ID# 273428
RECRUITING
Tama-shi
National Hospital Organization Saitama Hospital /ID# 266953
RECRUITING
Wako
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2020-11-16
Estimated Completion Date: 2029-02
Participants
Target number of participants: 96
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: AbbVie