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

Sponsor
Allergan (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04647214
Collaborator
(none)
230
Enrollment
25
Locations
27.9
Anticipated Duration (Months)
9.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    230 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    ARGOS - A Phase IV, Prospective, 18-month Study to Assess the Effectiveness and Safety of Bimatoprost Intracameral Implant (DURYSTA) in US Clinical Practice
    Actual Study Start Date :
    Mar 3, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Bimatoprost intracameral implant (DURYSTA) 10μg

    Patients with OAG or OHT who are scheduled for intracameral administration of a bimatoprost intracameral implant by their ophthalmologist.

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of treated eyes that did not receive additional Intraocular Pressure (IOP) -lowering intervention/therapy per standard medical care [Baseline to Month 6]

      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.

    Secondary Outcome Measures

    1. Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care [Baseline to Month 4]

      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.

    2. Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care [Baseline to Month 9]

      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.

    3. Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care [Baseline to Month 12]

      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.

    4. Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care [Baseline to Month 18]

      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.

    5. Time from bimatoprost intracameral implant to first additional IOP-lowering intervention/therapy [Baseline to Month 18]

      Time to first IOP-lowering intervention is defined as the time between treatment and IOP-lowering intervention.

    6. Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy [Baseline to Month 4]

      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.

    7. Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy [Baseline to Month 6]

      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.

    8. Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy [Baseline to Month 9]

      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.

    9. Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy [Baseline to Month 12]

      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.

    10. Proportion of treated eyes achieving predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy [Baseline to Month 18]

      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.

    11. Mean reduction in the number of topical IOP-lowering medications [Baseline to Month 4]

      A numerical count by class of drug of topical IOP lowering medications being taken.

    12. Mean reduction in the number of topical IOP-lowering medications [Baseline to Month 6]

      A numerical count by class of drug of topical IOP lowering medications being taken.

    13. Mean reduction in the number of topical IOP-lowering medications [Baseline to Month 9]

      A numerical count by class of drug of topical IOP lowering medications being taken.

    14. Mean reduction in the number of topical IOP-lowering medications [Baseline to Month 12]

      A numerical count by class of drug of topical IOP lowering medications being taken.

    15. Mean reduction in the number of topical IOP-lowering medications [Baseline to Month 18]

      A numerical count by class of drug of topical IOP lowering medications being taken.

    16. Proportion of treated eyes achieving complete success [Baseline to Month 4]

      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.

    17. Proportion of treated eyes achieving complete success [Baseline to Month 6]

      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.

    18. Proportion of treated eyes achieving complete success [Baseline to Month 9]

      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.

    19. Proportion of treated eyes achieving complete success [Baseline to Month 12]

      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.

    20. Proportion of treated eyes achieving complete success [Baseline to Month 18]

      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.

    21. Proportion of treated eyes achieving qualified success [Baseline to Month 4]

      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).

    22. Proportion of treated eyes achieving qualified success [Baseline to Month 6]

      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).

    23. Proportion of treated eyes achieving qualified success [Baseline to Month 9]

      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).

    24. Proportion of treated eyes achieving qualified success [Baseline to Month 12]

      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).

    25. Proportion of treated eyes achieving qualified success [Baseline to Month 18]

      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).

    26. Number of participants experiencing treatment emergent adverse events [Baseline to Month 18]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Angeles Eye Institute /ID# 240368 Culver City California United States 90232
    2 Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240364 La Jolla California United States 92093
    3 North Bay Eye Associates Inc. /ID# 240362 Petaluma California United States 94954-2387
    4 Pacific Eye Associates /ID# 240536 San Francisco California United States 94115
    5 Colorado Eye Institute /ID# 240798 Colorado Springs Colorado United States 80924-7003
    6 ICON Eye Care /ID# 240681 Grand Junction Colorado United States 81501-8180
    7 Eye Associates of Fort Meyers /ID# 244476 Fort Myers Florida United States 33901
    8 MedEye Associates /ID# 240374 Miami Florida United States 33143
    9 Dr. Andrew Gardner Logan, FL /ID# 240361 Tamarac Florida United States 33321
    10 Georgia Eye Partners /ID# 240061 Atlanta Georgia United States 30342
    11 Wiles Eye Center /ID# 240808 Kansas City Kansas United States 64118-4390
    12 Stiles Eyecare Excellence /ID# 240376 Overland Park Kansas United States 66213
    13 The Eye Care Institute /ID# 240367 Louisville Kentucky United States 40206
    14 Midwest Vision Research Foundation at Pepose Vision Institute /ID# 240537 Chesterfield Missouri United States 63017
    15 Ophthalmology Associates /ID# 240799 Saint Louis Missouri United States 63131
    16 Eye Associates of North Jersey /ID# 244585 Dover New Jersey United States 07801-1629
    17 Hudson Eye /ID# 240805 Jersey City New Jersey United States 07306-2929
    18 Duke Eye Center /ID# 244478 Durham North Carolina United States 27705
    19 Bergstrom Eye Research LLC /ID# 240363 Fargo North Dakota United States 58103
    20 META Medical Research Institute, LLC /ID# 240800 Dayton Ohio United States 45432-1400
    21 Oklahoma Eye Surgeons /ID# 240373 Oklahoma City Oklahoma United States 73112
    22 Glaucoma Associates of Texas /ID# 240682 Dallas Texas United States 75231
    23 El Paso Eye Surgeons, P.A. /ID# 240366 El Paso Texas United States 79902
    24 DCT Shah Eye Research Institut /ID# 240375 Mission Texas United States 78572
    25 The Eye Centers of Racine and Kenosha LTD /ID# 240059 Racine Wisconsin United States 53405

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: ALLERGAN INC., Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT04647214
    Other Study ID Numbers:
    • MED-MA-EYE-0648
    First Posted:
    Nov 30, 2020
    Last Update Posted:
    Feb 23, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Glaucoma, Open-Angle
    Ocular Hypertension

    Study Results

    No Results Posted as of Feb 23, 2022