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

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

Study Overview

• Status: Recruiting
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: AGN-193408 SR; Other: Lumigan; Other: Sham Administration; Other: Lumigan Vehicle; Drug: AGN-193408 SR; Other: Sham Administration; Other: Lumigan Vehicle

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Japan
  • Kanagawa
    • Sagamihara-shi, Kanagawa, Japan, 252-0375
      • Completed
      • Kitasato University Hospital /ID# 238880
  • Shimane
    • Izumo-shi, Shimane, Japan, 693-8501
      • Completed
      • Shimane University Hospital /ID# 238641
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8655
      • Recruiting
      • The University of Tokyo Hospital /ID# 238871
  • Yamanashi
    • Chuo-shi, Yamanashi, Japan, 409-3821
      • Recruiting
      • University of Yamanashi Hospital /ID# 238642
• United States
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Recruiting
      • Walman Eye Center /ID# 252153
  • California
    • Glendale, California, United States, 91204-2500
      • Recruiting
      • Global Research Management /ID# 241699
    • Inglewood, California, United States, 90301
      • Completed
      • United Medical Research Institute /ID# 241701
    • Irvine, California, United States, 92604
      • Recruiting
      • Lakeside Vision Center /ID# 241698
    • Newport Beach, California, United States, 92663-3637
      • Recruiting
      • The Eye Research Foundation /ID# 234528
    • Sacramento, California, United States, 95815
      • Recruiting
      • Sacramento Eye Consultants /ID# 241697
      • Contact: Site Coordinator; Phone Number: 916-649-1515
    • Torrance, California, United States, 90505
      • Recruiting
      • Wolstan & Goldberg Eye Associates /ID# 241700
    • Torrance, California, United States, 90505
      • Completed
      • Premiere Practice Management LLC /ID# 235957
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Recruiting
      • Connecticut Eye Consultants P.C. /ID# 235862
  • Florida
    • Crystal River, Florida, United States, 34429
      • Recruiting
      • Nature Coast Clinical Research - Crystal River /ID# 237781
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Jacksonville, Florida, United States, 32209-6533
      • Completed
      • University of Florida Health Ophthalmology - Jacksonville /ID# 243122
    • Stuart, Florida, United States, 34994
      • Recruiting
      • East Florida Eye Institute /ID# 235762
    • Tamarac, Florida, United States, 33321
      • Recruiting
      • Logan Ophthalmic Research Inc. /ID# 252087
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Recruiting
      • Coastal Research Associates /ID# 234649
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Completed
      • Midwest Medical Advisors Inc /ID# 235845
    • Indianapolis, Indiana, United States, 46202
      • Completed
      • Indiana University - Glick Eye Institute /ID# 235887
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Recruiting
      • Ophthalmic Consultants of Boston /ID# 236535
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Completed
      • Tekwani Vision Center /ID# 235149
  • New Jersey
    • Newark, New Jersey, United States, 07103-2425
      • Completed
      • Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 234365
    • South Orange, New Jersey, United States, 07079-1855
      • Recruiting
      • Northern New Jersey Eye Institute PA /ID# 241545
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Completed
      • Asheville Eye Associates /ID# 234963
    • Winston-Salem, North Carolina, United States, 27101
      • Recruiting
      • James D Branch MD /ID# 234560
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Recruiting
      • Oklahoma Eye Surgeons /ID# 252089
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Completed
      • Drs Fine Hoffman & Sims LLC /ID# 235919
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Recruiting
      • Scott and Christie and Associates /ID# 252284
  • Tennessee
    • Smyrna, Tennessee, United States, 37167
      • Recruiting
      • Advancing Vision Research /ID# 236683
  • Utah
    • Saint George, Utah, United States, 84790
      • Recruiting
      • St. George Eye Center /ID# 236200
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Recruiting
      • Piedmont Eye Center /ID# 246455
    • Roanoke, Virginia, United States, 24011
      • Completed
      • Vistar Eye Center /ID# 234811

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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]) in the study eye (Cohort 3 only).

Exclusion Criteria:

• 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:

  • 3 years: intraocular fluocinolone acetonide
  • 6 months: intraocular corticosteroid(s) other than fluocinolone; any injectable periocular or sub-Tenon's/subconjunctival corticosteroid
  • 2 months: systemic (eg, oral, intramuscular, intravenous) or topical ocular corticosteroids
  • 2 weeks: dermal corticosteroids applied to skin of the eyelid(s), around the eye, or adnexa.
• Anticipated use of other topical ocular medications in either eye except for permitted interventions.

• The anticipated wearing of contact lenses in the study eye (Cohort 1) and both eyes (Cohorts 2 and 3) during the study that deviates from the following (contact lens wear is allowed during the study, but is to be temporarily discontinued before study visits, and before and after an Administration Day according to the following):

  • Use of soft lenses should be discontinued at least 3 days prior to Baseline, and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to Baseline
  • Use of soft lenses should be discontinued at least 3 days and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to a scheduled study visit or Administration Day visit
  • Use of contact lenses of any kind should be discontinued for 1 week following any AGN-193408 SR administration
• Central corneal thickness of < 480 or > 620 micrometers in both eyes.
• Visual field loss in the study eye that, in the opinion of the investigator, is functionally significant (eg, split fixation, field defect within the central 10 degrees that is visually significant or likely to cause central visual impairment upon progression) or shows evidence of progressive visual field loss within the year prior to Baseline.
• Evidence of macular edema in either eye during screening or in participant's medical history.
• At Screening, evidence of posterior synechia behind the iris inferiorly in the study eye that in the investigator's opinion may inhibit the ability to safely receive at least 1 AGN-193408 SR implant (Cohort 3 only).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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.; Other: Lumigan; Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost; Other Names: Active Comparator; Drug: 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 behind the study eye.
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.	Drug: 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.; Other: Lumigan; Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost; Other Names: Active Comparator; Drug: 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 behind the study eye.
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.	Drug: 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.; Other: Lumigan; Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost; Other Names: Active Comparator; Other: Sham Administration; Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.; Other: 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.; Other Names: Vehicle; Drug: 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 behind the study eye.; Other: Sham Administration; Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.; Other: 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.; Other Names: Vehicle
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.	Drug: 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.; Other: Lumigan; Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost; Other Names: Active Comparator; Other: Sham Administration; Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.; Other: 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.; Other Names: Vehicle; Drug: 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 behind the study eye.; Other: Sham Administration; Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.; Other: 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.; Other Names: Vehicle
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 behind 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.	Drug: 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.; Other: Lumigan; Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost; Other Names: Active Comparator; Other: Sham Administration; Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.; Other: 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.; Other Names: Vehicle; Drug: 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 behind the study eye.; Other: Sham Administration; Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.; Other: 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.; Other Names: Vehicle
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 behind 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.	Drug: 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.; Other: Lumigan; Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost; Other Names: Active Comparator; Other: Sham Administration; Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.; Other: 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.; Other Names: Vehicle; Drug: 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 behind the study eye.; Other: Sham Administration; Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.; Other: 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.; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants experiencing treatment emergent adverse events		Baseline to Month 24
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 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Rescue Treatment or Re-Treatment in the Study Eye	Time to rescue treatment or the second treatment is defined as the time between the first treatment and the second treatment in the study eye.	Baseline to Month 24

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Open-angle glaucoma; Ocular hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: 1833-201-407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No