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

Ocular Hypertension Clinical Trial

— ARGOS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04647214
• Other study ID #: MED-MA-EYE-0648
• Status: Recruiting
• Start date: March 3, 2021
• Est. completion date: July 23, 2024

Study information

• Verified date: June 2024
• Source: Allergan
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: July 23, 2024
• Est. primary completion date: July 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open-angle Glaucoma

Locations

Country	Name	City	State
United States	Georgia Eye Partners /ID# 240061	Atlanta	Georgia
United States	John Hopkins Wilmer Eye Institute /ID# 243701	Bethesda	Maryland
United States	New York Eye Surgery Associates, PLLC /ID# 244592	Bronx	New York
United States	Midwest Vision Research Foundation at Pepose Vision Institute /ID# 240537	Chesterfield	Missouri
United States	Colorado Eye Institute /ID# 240798	Colorado Springs	Colorado
United States	Scott and Christie and Associates /ID# 244574	Cranberry Township	Pennsylvania
United States	Angeles Eye Institute /ID# 240368	Culver City	California
United States	Glaucoma Associates of Texas /ID# 240682	Dallas	Texas
United States	Glaucoma Associates of Texas /ID# 253289	Dallas	Texas
United States	META Medical Research Institute, LLC /ID# 240800	Dayton	Ohio
United States	Eye Associates of North Jersey /ID# 244585	Dover	New Jersey
United States	Duke Eye Center /ID# 244478	Durham	North Carolina
United States	El Paso Eye Surgeons, P.A. /ID# 240366	El Paso	Texas
United States	Kovach Eye Institute /ID# 244581	Elmhurst	Illinois
United States	Bergstrom Eye Research LLC /ID# 240363	Fargo	North Dakota
United States	Eye Associates of Fort Meyers /ID# 244476	Fort Myers	Florida
United States	ICON Eye Care /ID# 240681	Grand Junction	Colorado
United States	Hudson Eye /ID# 240805	Jersey City	New Jersey
United States	Wiles Eye Center /ID# 240808	Kansas City	Missouri
United States	Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240364	La Jolla	California
United States	Glaucoma Care Center /ID# 252021	Livingston	New Jersey
United States	American Institute of Research /ID# 247820	Los Angeles	California
United States	The Eye Care Institute /ID# 240367	Louisville	Kentucky
United States	MedEye Associates /ID# 240374	Miami	Florida
United States	DCT Shah Eye Research Institut /ID# 240375	Mission	Texas
United States	Vanderbilt University Medical Center /ID# 244577	Nashville	Tennessee
United States	MaculaCare PLLC /ID# 244593	New York	New York
United States	Oklahoma Eye Surgeons /ID# 240373	Oklahoma City	Oklahoma
United States	New York New Jersey Eye Institute /ID# 244590	Orangeburg	New York
United States	Stiles Eyecare Excellence /ID# 240376	Overland Park	Kansas
United States	North Bay Eye Associates Inc. /ID# 240362	Petaluma	California
United States	The Eye Centers of Racine and Kenosha LTD /ID# 240059	Racine	Wisconsin
United States	Ophthalmology Associates /ID# 240799	Saint Louis	Missouri
United States	Pacific Eye Associates /ID# 240536	San Francisco	California
United States	Center for Sight - Sarasota /ID# 244578	Sarasota	Florida
United States	Newsom Eye & Laser Center /ID# 253287	Sebring	Florida
United States	Dr. Andrew Gardner Logan, FL /ID# 240361	Tamarac	Florida
United States	Your Eye Specialists /ID# 253286	Weston	Florida
United States	Burlington County Eye Physicians /ID# 244594	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of participants experiencing treatment emergent adverse events		Baseline to Month 18