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Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891446
Recruitment Status : Enrolling by invitation
First Posted : March 27, 2019
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Bimatoprost SR Other: Standard of Care Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lead-in study 192024-091 or -092 or -095

Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered.

Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.

 Other: Standard of Care
Standard of care treatment based on investigator's judgement.
Experimental: Lead-in study 192024-093 Stage 1

Participants in Lead-in Study 192024-093 Stage 1 and participants in Stage 2 who received only 1 Bimatoprost administration due to safety concerns:

Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered.

Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.

 Other: Standard of Care
Standard of care treatment based on investigator's judgement.
Experimental: Lead-in study 192024-093 Stage 2

Participants in Lead-in Study 192024-093 Stage 2 who received only 2 Bimatoprost administrations or 1 Bimatoprost administration due to sustained efficacy:

Study eye (Eye that received Bimatoprost SR in the lead-in study): 2 additional administrations of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.

 Drug: Bimatoprost SR
Intraocular implant
Other Name: DURYSTA

Other: Standard of Care
Standard of care treatment based on investigator's judgement.
Experimental: Lead-in study ARGOS
Study eye (Eye that received Bimatoprost SR first in the lead-in study): 2 additional administrations of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 2 additional administrations of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart. Untreated Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Untreated fellow eye will receive only standard of care, based on the investigator's judgment.
 Drug: Bimatoprost SR
Intraocular implant
Other Name: DURYSTA

Other: Standard of Care
Standard of care treatment based on investigator's judgement.


Outcome Measures
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Primary Outcome Measures :
  1. Duration of effect of Bimatoprost SR [ Time Frame: Approximately 24 months ]
    Retreatment or rescue administered for IOP lowering, determined by the investigator.

  2. Number of patients experiencing a treatment emergent adverse event [ Time Frame: Approximately 24 months ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR.
  • Participants who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and received DURYSTA.

Exclusion Criteria:

  • Female participants who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study.
  • Concurrent or anticipated enrollment in another investigational drug or device study during the present study.
  • Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study.
  • Participants who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092.
  • For patients from the ARGOS lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow eye.
Contacts and Locations
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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): NCT03891446


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03891446    
Other Study ID Numbers: 1698-302-007
2018-003597-26 ( EudraCT Number )
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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 and 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing, please refer to the link below
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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
URL: https://vivli.org/ourmember/abbvie/

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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
Keywords provided by AbbVie:
Open-Angle Glaucoma
Ocular Hypertension
Bimatoprost
DURYSTA
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Bimatoprost
Antihypertensive Agents