RecruitingPhase 1Phase 2NCT04499248

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

Sponsor

AbbVie

Enrollment

96 participants

Start Date

Nov 16, 2020

Study Type

INTERVENTIONAL

Conditions

Open Angle Glaucoma Ocular Hypertension

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new slow-release eye drop medication (AGN-193408 SR) for treating open-angle glaucoma or high eye pressure (ocular hypertension). High eye pressure can damage the optic nerve over time, and this drug aims to lower that pressure. **You may be eligible if...** - You have been diagnosed with open-angle glaucoma or elevated eye pressure in both eyes - You have previously had cataract surgery (you are pseudophakic) - You are willing to temporarily pause your current eye pressure medications during the study - You meet certain eye pressure level requirements at screening **You may NOT be eligible if...** - You have narrow-angle or angle-closure glaucoma - You have had certain eye surgeries other than cataract surgery - You have active eye infections or inflammation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAGN-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.

OTHERLumigan

Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost

OTHERSham Administration

Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.

OTHERLumigan 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.

DRUGAGN-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.

OTHERSham Administration

Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.

OTHERLumigan 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

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