18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA) (ARGOS)

ARGOS - A Phase IV, Prospective, 18-month Study to Assess the Effectiveness and Safety of Bimatoprost Intracameral Implant (DURYSTA) in US Clinical Practice

Study to collect effectiveness and safety data after administration of a bimatoprost intracameral implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Study Overview

• Status: Recruiting
• Conditions: Ocular Hypertension; Open-angle Glaucoma

• Study Type: Observational
• Enrollment (Estimated): 230

Contacts and Locations

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

Study Locations

• United States
  • California
    • Culver City, California, United States, 90232
      • Recruiting
      • Angeles Eye Institute /ID# 240368
    • La Jolla, California, United States, 92093
      • Recruiting
      • Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240364
    • Los Angeles, California, United States, 90027
      • Completed
      • American Institute of Research /ID# 247820
    • Petaluma, California, United States, 94954-2387
      • Recruiting
      • North Bay Eye Associates Inc. /ID# 240362
    • San Francisco, California, United States, 94115
      • Completed
      • Pacific Eye Associates /ID# 240536
  • Colorado
    • Colorado Springs, Colorado, United States, 80924-7003
      • Recruiting
      • Colorado Eye Institute /ID# 240798
    • Grand Junction, Colorado, United States, 81501-8180
      • Recruiting
      • ICON Eye Care /ID# 240681
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Completed
      • Eye Associates of Fort Meyers /ID# 244476
    • Miami, Florida, United States, 33143
      • Recruiting
      • MedEye Associates /ID# 240374
    • Sarasota, Florida, United States, 34239
      • Completed
      • Center for Sight - Sarasota /ID# 244578
    • Sebring, Florida, United States, 33870
      • Recruiting
      • Newsom Eye & Laser Center /ID# 253287
    • Tamarac, Florida, United States, 33321
      • Recruiting
      • Dr. Andrew Gardner Logan, FL /ID# 240361
    • Weston, Florida, United States, 33326
      • Completed
      • Your Eye Specialists /ID# 253286
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Georgia Eye Partners /ID# 240061
  • Illinois
    • Elmhurst, Illinois, United States, 60126-2821
      • Recruiting
      • Kovach Eye Institute /ID# 244581
  • Kansas
    • Overland Park, Kansas, United States, 66213
      • Completed
      • Stiles Eyecare Excellence /ID# 240376
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Recruiting
      • The Eye Care Institute /ID# 240367
  • Maryland
    • Bethesda, Maryland, United States, 20817-1805
      • Recruiting
      • John Hopkins Wilmer Eye Institute /ID# 243701
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Recruiting
      • Midwest Vision Research Foundation at Pepose Vision Institute /ID# 240537
    • Kansas City, Missouri, United States, 64118-4390
      • Recruiting
      • Wiles Eye Center /ID# 240808
    • Saint Louis, Missouri, United States, 63131
      • Recruiting
      • Ophthalmology Associates /ID# 240799
  • New Jersey
    • Dover, New Jersey, United States, 07801-1629
      • Recruiting
      • Eye Associates of North Jersey /ID# 244585
    • Jersey City, New Jersey, United States, 07306-2929
      • Recruiting
      • Hudson Eye /ID# 240805
    • Livingston, New Jersey, United States, 07039
      • Recruiting
      • Glaucoma Care Center /ID# 252021
    • Willingboro, New Jersey, United States, 08046-1109
      • Completed
      • Burlington County Eye Physicians /ID# 244594
  • New York
    • Bronx, New York, United States, 10469
      • Completed
      • New York Eye Surgery Associates, PLLC /ID# 244592
    • New York, New York, United States, 10021
      • Recruiting
      • MaculaCare PLLC /ID# 244593
    • Orangeburg, New York, United States, 10962-2185
      • Recruiting
      • New York New Jersey Eye Institute /ID# 244590
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke Eye Center /ID# 244478
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Completed
      • Bergstrom Eye Research LLC /ID# 240363
  • Ohio
    • Dayton, Ohio, United States, 45432-1400
      • Recruiting
      • META Medical Research Institute, LLC /ID# 240800
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Recruiting
      • Oklahoma Eye Surgeons /ID# 240373
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Recruiting
      • Scott and Christie and Associates /ID# 244574
  • Tennessee
    • Nashville, Tennessee, United States, 37232-0011
      • Recruiting
      • Vanderbilt University Medical Center /ID# 244577
  • Texas
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Glaucoma Associates of Texas /ID# 240682
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Glaucoma Associates of Texas /ID# 253289
    • El Paso, Texas, United States, 79902
      • Recruiting
      • El Paso Eye Surgeons, P.A. /ID# 240366
    • Mission, Texas, United States, 78572
      • Completed
      • DCT Shah Eye Research Institut /ID# 240375
  • Wisconsin
    • Racine, Wisconsin, United States, 53405
      • Recruiting
      • The Eye Centers of Racine and Kenosha LTD /ID# 240059

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The study population will include US patients with OAG or OHT who are scheduled for administration of a bimatoprost intracameral implant by their ophthalmologist.

Description

Inclusion Criteria:

- Patient diagnosed with OAG or OHT who is scheduled to receive a bimatoprost intracameral implant in at least one eye.

Exclusion Criteria:

- A history of any of the following ocular surgeries in the eye due to receive a bimatoprost intracameral implant:Ahmed Glaucoma Valve, Baerveldt shunt, Ex-Press glaucoma shunt implantation, Molteno shunt, Trabeculectomy, Vitrectomy, retinal surgery, CyPass Micro-Stent or Anterior Chamber Intraocular Lens (AC IOL) placement.

• Concurrent or anticipated enrollment in an interventional clinical trial involving either an investigational medicinal product or medical device.
• Previous enrollment in another Allergan bimatoprost intracameral implant study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Bimatoprost intracameral implant (DURYSTA) 10μg; Patients with OAG or OHT who are scheduled for intracameral administration of a bimatoprost intracameral implant by their ophthalmologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of treated eyes that did not receive additional Intraocular Pressure (IOP) -lowering intervention/therapy per standard medical care	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 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care	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 4
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care	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 9
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care	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 12
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care	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 18
Time from bimatoprost intracameral implant to first additional IOP-lowering intervention/therapy	Time to first IOP-lowering intervention is defined as the time between treatment and IOP-lowering intervention.	Baseline to Month 18
Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy	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 4
Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy	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 6
Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy	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 9
Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy	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 12
Proportion of treated eyes achieving predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy	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 18
Mean reduction in the number of topical IOP-lowering medications	A numerical count by class of drug of topical IOP lowering medications being taken.	Baseline to Month 4
Mean reduction in the number of topical IOP-lowering medications	A numerical count by class of drug of topical IOP lowering medications being taken.	Baseline to Month 6
Mean reduction in the number of topical IOP-lowering medications	A numerical count by class of drug of topical IOP lowering medications being taken.	Baseline to Month 9
Mean reduction in the number of topical IOP-lowering medications	A numerical count by class of drug of topical IOP lowering medications being taken.	Baseline to Month 12
Mean reduction in the number of topical IOP-lowering medications	A numerical count by class of drug of topical IOP lowering medications being taken.	Baseline to Month 18
Proportion of treated eyes achieving complete success	Complete success is defined as treated eyes with IOP <=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant.	Baseline to Month 4
Proportion of treated eyes achieving complete success	Complete success is defined as treated eyes with IOP <=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant.	Baseline to Month 6
Proportion of treated eyes achieving complete success	Complete success is defined as treated eyes with IOP <=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant.	Baseline to Month 9
Proportion of treated eyes achieving complete success	Complete success is defined as treated eyes with IOP <=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant.	Baseline to Month 12
Proportion of treated eyes achieving complete success	Complete success is defined as treated eyes with IOP <=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant.	Baseline to Month 18
Proportion of treated eyes achieving qualified success	Partial success is defined as treated eyes with IOP <=18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT).	Baseline to Month 4
Proportion of treated eyes achieving qualified success	Partial success is defined as treated eyes with IOP <=18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT).	Baseline to Month 6
Proportion of treated eyes achieving qualified success	Partial success is defined as treated eyes with IOP <=18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT).	Baseline to Month 9
Proportion of treated eyes achieving qualified success	Partial success is defined as treated eyes with IOP <=18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT).	Baseline to Month 12
Proportion of treated eyes achieving qualified success	Partial success is defined as treated eyes with IOP ≤18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT).	Baseline to Month 18
Number of participants experiencing treatment emergent adverse events		Baseline to Month 18

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: ALLERGAN INC., Allergan

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Estimated): July 23, 2024
• Study Completion (Estimated): July 23, 2024

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
• Other Study ID Numbers: MED-MA-EYE-0648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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