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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04647214
Recruitment Status : Recruiting
First Posted : November 30, 2020
Last Update Posted : December 29, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

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
Open-angle Glaucoma Ocular Hypertension

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Study Type : Observational
Estimated 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 : March 3, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

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.



Primary Outcome Measures :
  1. Proportion of treated eyes that did not receive additional Intraocular Pressure (IOP) -lowering intervention/therapy per standard medical care [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to Month 18 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647214


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: ALLERGAN INC. Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04647214    
Other Study ID Numbers: MED-MA-EYE-0648
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: December 29, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Glaucoma, Open-Angle
Ocular Hypertension
Glaucoma
Eye Diseases