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AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension
Sponsor: AbbVie
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
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2020-11-16
Completion Date
2029-02
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (49)
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
Advanced Research, LLC /ID# 276987
Deerfield Beach, 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
Nv Eye Surgery - Henderson /ID# 276925
Henderson, Nevada, 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