AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension
A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
1 other identifier
interventional
100
2 countries
49
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2020
Longer than P75 for phase_1
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedStudy Start
First participant enrolled
November 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
May 22, 2026
May 1, 2026
8.4 years
July 31, 2020
May 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Hour 0 Intraocular Pressure (IOP) in the Study Eye
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.
Baseline to Month 36
Number of participants experiencing treatment emergent adverse events
Baseline to Month 36
Secondary Outcomes (1)
Time to Rescue Treatment or Re-Treatment in the Study Eye
Baseline to Month 36
Study Arms (6)
Cohort 1 -Dose A
EXPERIMENTALSingle 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.
Cohort 1 - Dose B
EXPERIMENTALSingle 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.
Cohort 2 - Dose A
EXPERIMENTALAGN-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.
Cohort 2 - Dose B
EXPERIMENTALAGN-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.
Cohort 3 - Dose A
EXPERIMENTALAGN-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.
Cohort 3 - Dose B
EXPERIMENTALAGN-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.
Interventions
Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 2.
Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.
Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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:
- years: intraocular fluocinolone acetonide
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (49)
Horizon Eye Specialists & Lasik Center - Sun City /ID# 252153
Sun City, Arizona, 85351, United States
Global Research Management /ID# 241699
Glendale, California, 91204-2500, United States
United Medical Research Institute /ID# 241701
Inglewood, California, 90301, United States
Lakeside Vision Center /ID# 241698
Irvine, California, 92604, United States
The Eye Research Foundation /ID# 234528
Newport Beach, California, 92663-3637, United States
Sacramento Eye Consultants /ID# 241697
Sacramento, California, 95815, United States
Premiere Practice Management LLC /ID# 235957
Torrance, California, 90505, United States
Wolstan & Goldberg Eye Associates /ID# 241700
Torrance, California, 90505, United States
Connecticut Eye Consultants P.C. /ID# 235862
Danbury, Connecticut, 06810, United States
Brandon Eye Associates - Brandon /ID# 276600
Brandon, Florida, 33511, United States
Nature Coast Clinical Research - Crystal River /ID# 237781
Crystal River, Florida, 34429, United States
Advanced Research, LLC /ID# 276987
Deerfield Beach, Florida, 33064-1346, United States
University of Florida Health Ophthalmology - Jacksonville /ID# 243122
Jacksonville, Florida, 32209-6533, United States
East Florida Eye Institute /ID# 235762
Stuart, Florida, 34994, United States
Logan Ophthalmic Research Inc. /ID# 252087
Tamarac, Florida, 33321, United States
Coastal Research Associates /ID# 234649
Roswell, Georgia, 30076, United States
Thomas Eye Group PC /ID# 266775
Sandy Springs, Georgia, 30328, United States
University of Illinois Hospital and Health Sciences System /ID# 253630
Chicago, Illinois, 60607, United States
Midwest Medical Advisors Inc /ID# 235845
Carmel, Indiana, 46290, United States
Indiana University - Glick Eye Institute /ID# 235887
Indianapolis, Indiana, 46202, United States
Ophthalmic Consultants of Boston /ID# 236535
Boston, Massachusetts, 02129, United States
Fraser Eye Care Center /ID# 267100
Fraser, Michigan, 48026, United States
Midwest Vision Research Foundation at Pepose Vision Institute /ID# 267094
Chesterfield, Missouri, 63017, United States
Silverstein Eye Centers /ID# 266767
Kansas City, Missouri, 64133, United States
Tekwani Vision Center /ID# 235149
St Louis, Missouri, 63128, United States
Nv Eye Surgery - Henderson /ID# 276925
Henderson, Nevada, 89052, United States
Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 234365
Newark, New Jersey, 07103-2425, United States
Northern New Jersey Eye Institute /ID# 241545
South Orange, New Jersey, 07079, United States
Asheville Eye Associates /ID# 234963
Asheville, North Carolina, 28803, United States
Private Practice - Dr. James D. Branch /ID# 234560
Winston-Salem, North Carolina, 27101, United States
The Ohio State University /ID# 267590
Columbus, Ohio, 43210, United States
Oklahoma Eye Surgeons /ID# 252089
Oklahoma City, Oklahoma, 73112, United States
Drs Fine Hoffman & Sims LLC /ID# 235919
Eugene, Oregon, 97401, United States
Scott and Christie and Associates /ID# 252284
Cranberry Township, Pennsylvania, 16066, United States
Eye Specialty Group /ID# 252201
Memphis, Tennessee, 38120, United States
Vanderbilt Eye Institute /ID# 266915
Nashville, Tennessee, 37232-0025, United States
Advancing Vision Research /ID# 236683
Smyrna, Tennessee, 37167, United States
Macro Trials (SMO/Network/Consortium) /ID# 266772
Austin, Texas, 78731, United States
San Antonio Eye Center /ID# 272087
San Antonio, Texas, 78215, United States
St. George Eye Center /ID# 236200
St. George, Utah, 84790, United States
Piedmont Eye Center /ID# 246455
Lynchburg, Virginia, 24502, United States
Vistar Eye Center /ID# 234811
Roanoke, Virginia, 24011, United States
Kitasato University Hospital /ID# 238880
Sagamihara-shi, Kanagawa, 252-0375, Japan
National Hospital Organization Saitama Hospital /ID# 266953
Wako, Saitama, 351-0102, Japan
Duplicate_Shimane University Hospital /ID# 238641
Izumo-shi, Shimane, 693-8501, Japan
The University of Tokyo Hospital /ID# 238871
Bunkyo-ku, Tokyo, 113-8655, Japan
Nippon Medical School Tama Nagayama Hospital /ID# 273428
Tama-shi, Tokyo, 206-8512, Japan
University of Yamanashi Hospital /ID# 238642
Chuo-shi, Yamanashi, 409-3898, Japan
Hayashi eye hospital /ID# 267604
Fukuoka, 812-0011, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2020
First Posted
August 5, 2020
Study Start
November 16, 2020
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.