AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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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 the USA