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PRESERFLO® MicroShunt Extension Study

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: NCT04333433
Recruitment Status : Not yet recruiting
First Posted : April 3, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
InnFocus Inc.

Brief Summary:
This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.

Condition or disease Intervention/treatment
Primary Open-angle Glaucoma Device: PRESERFLO® MicroShunt Procedure: Trabeculectomy

Detailed Description:
The objective of this study is to evaluate the long-term safety of the PRESERFLO® MicroShunt in subjects with Primary Open-Angle Glaucoma who have completed their Month 24 Follow-Up Visit in the INN-005 clinical study, by collecting safety data through 5 years post-operative follow-up.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Concurrent Controlled, Open-Label, Multicenter Clinical Study to Assess the Long-Term Safety of the PRESERFLO® MicroShunt in Subjects With Primary Open-Angle Glaucoma Who Have Completed Participation in the INN-005 Randomized Controlled Study.
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
MicroShunt treatment group
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device
Device: PRESERFLO® MicroShunt
Device surgically implanted
Other Name: InnFocus MicroShunt® Glaucoma Drainage System

Trabeculectomy control arm
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure
Procedure: Trabeculectomy
The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.




Primary Outcome Measures :
  1. Incidence of sight-threatening adverse events [ Time Frame: Through 5 years postoperative follow-up ]
    Incidence of sight-threatening adverse events, including but are not limited to events such as endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, and aqueous misdirection



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study population includes all living subjects who have completed the Month 24 Follow-Up Visit of the INN-005 clinical study after randomization to either the PRESERFLO® MicroShunt treatment arm or the Trabeculectomy control arm, and who are willing and able to extend their study participation and return for up to three (3) additional annual follow-up visits through post-operative Month 60. Up to 629 subjects may be enrolled at up to 24 sites located in the United States and at up to 5 sites located in Europe
Criteria

Inclusion Criteria:

  1. Subject has completed their Month 24 Follow-Up Visit in the INN-005 clinical study conducted under IDE G130028.
  2. Subject was randomized into the INN-005 study and received the PRESERFLO® MicroShunt device or trabeculectomy. (Subjects who have had the device explanted, or replaced with another device, may be included).
  3. Subject is willing and able to comply with all study requirements, including signing an informed consent form.

Exclusion Criteria:

1. Subject has exceeded the timeframe for the Month 60 Follow-Up Visit prior to enrollment for participation in this long-term follow-up 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): NCT04333433


Contacts
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Contact: Sharon J Herbert, PhD 415-268-9100 ext 9059 Sharon.Herbert@santen.com

Locations
Show Show 24 study locations
Sponsors and Collaborators
InnFocus Inc.
Investigators
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Study Director: Paul Palmberg, MD, PhD Bascolm Palmer Eye Institute

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Responsible Party: InnFocus Inc.
ClinicalTrials.gov Identifier: NCT04333433    
Other Study ID Numbers: INN005 - EXT
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by InnFocus Inc.:
POAG
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases